Camrelizumab Combined With Apatinib and Capecitabine in Patients With Advanced Unresectable Biliary Tract Cancer.

Learn more about:
Related Clinical Trial
Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer Phase Ib/II Single-arm Study of mFOLFOX6, Bevacizumab and Atezolizumab in Advanced Biliary Tract Cancer A Safety and Efficacy Study of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer Metabolic Stress-induced Exercise to Prevent Loss of Muscle Mass in Patients With Pancreatic and Biliary Tract Cancer The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer A Study of ABL001 in Combination With Irinotecan or Paclitaxel in Patients With Advanced or Metastatic Solid Tumors Prognostic and Predictive Markers of Response to Treatment in Patients With Bile Duct Cancer: ACABi PRONOBIL Study Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy Predicting Disease Progression and/or Recurrence in Cancer Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab Endoluminal Radiofrequency Ablation for the Treatment of Malignant Biliary Stenosis A Phase 1/2 Study of SC-43 in Combination With Cisplatin The Purpose of This Trial is to Determine if Regorafenib Plus Durvalumab (MEDI4736) is Safe and Effective in Treatment of Chemo Refractory Advanced Biliary Tract Cancers Phase II Study of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Biliary Tract Cancer Camrelizumab Combined With Apatinib and Capecitabine in Patients With Advanced Unresectable Biliary Tract Cancer. A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer A Clinical Study of PD-L1 Antibody ZKAB001 Combined With Capecitabine in Resected Biliary Tract Cancer A Trial of SHR1258 in Patients With Biliary Tract Cancer Perception Prognosis, Goals of Treatment, and Communication IL-2 Expressing, Attenuated Salmonella Typhimurium in Unresectable Hepatic Spread A Study to Assess the Safety, Tolerability and Anti-tumour Activity of Ascending Doses of Selumetinib in Combination With MEDI4736 and Selumetinib in Combination With MEDI4736 and Tremelimumab in Patients With Advanced Solid Tumours Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors Tremelimumab With Chemoembolization or Ablation for Liver Cancer Preoperative Nutritional Support in Malnutritional Cancer Patients Multibending vs Conventional Endoscope for Direct Peroral Cholangioscopy Surgical Outcomes Database For Faculty of Hepatopancreatic Biliary Surgery SOX Sequential S-1 in Advanced Biliary Tract Carcinoma(BTC)and Pancreatic Cancer Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005) Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control Covered Versus Uncovered SEMS for Palliation of Malignant Biliary Strictures. Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions Early Palliative Care on Quality of Life of Advanced Cancer Patients Patient Activation Through Counseling, Exercise and Mobilization Extracellular RNA Markers of Liver Disease and Cancer X-MAS Biliary Study With Covered Biliary Stent A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507 Anti-HER2 Therapy in Patients of HER2 Positive Metastatic Carcinoma of Digestive System The Efficacy and Safety of Nab-paclitaxel Plus S-1 in First-line Treatment of Advanced Biliary Tract Adenocarcinoma XELOX in Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy Phase II Study of Refametinib, a MEK Inhibitor, as Second-line Treatment in Advanced Biliary Tract Adenocarcinoma Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma A Trial Evaluating Surufatinib Efficacy and Safety in Biliary Tract Carcinoma Patients Study of Surufatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma Combination of Targeted and Immunotherapy for Advanced Biliary Tract and Esophagogastric Gastric Cancer A Study of AbGn-107 in Patients With Gastric, Colorectal, Pancreatic or Biliary Cancer Gemcitabine and Capecitabine to Treat Patients With Advanced Pancreatic and Biliary Cancers A Prospective Cohort Study of Patients With Hepatobiliary Cancer Treated With Immune Checkpoint Inhibitors GTX Regimen for Biliary Cancers Phase II Study of Gemcitabine and TS-1 in Biliary Trat Cancer A Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Clinical Activity Of RO7119929 (TLR7 Agonist) In Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases A Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic BTC Varlitinib in Combination With Gemcitabine and Cisplatin for Treatment naïve Advanced or Metastatic BTC Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer FOLFIRINOX for 2nd-line Treatment of BTC Study of PD-1 Inhibitor in Combination With Gemcitabine/Cisplatin for Advancer BTCs FOLFIRI as Salvage Treatment in Metastatic Biliary Tract Cancer (BTC) Patients Who Were Failed After Gemcitabine Containing Chemotherapy: A Phase II Single Arm Prospective Study Pemetrexed in Combination With Erlotinib as a Salvage Treatment in Patients With Metastatic Biliary Tract Cancer (BTC) Who Failed Gemcitabine Containing Chemotherapy: A Phase II Single Arm Prospective Study Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Therapy Study of Pembrolizumab in Metastatic Biliary Tract Cancer as Second-line Treatment After Failing to at Least One Cytotoxic Chemotherapy Regimen: Integration of Genomic Analysis to Identify Predictive Molecular Subtypes A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer Gemcitabine/Cisplatin/S-1(GCS) Combination Therapy for Patients With Advanced Biliary Tract Cancer Phase II Study of Gemcitabine Versus S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer Docetaxel and Oxaliplatin Combination With Locally Advanced or Metastatic Biliary Tract Cancer A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer Study of S-1 Oxaliplatin (SOX) for Biliary Tract Cancer (BTC) (Ampullary Adenocarcinoma) Trastuzumab in HER2-positive Biliary Tract Cancer Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer Who Failed Gemcitabine-based Combination Chemotherapy Study of D07001-Softgel Capsules in Subjects With Gastrointestinal Cancer in Dose-Escalation Phase and in Subjects With Biliary Tract Cancer in Dose-Expansion Phase Second Line Therapy in Advanced Biliary Tract Cancer Phase II Study of FOLFOXIRI in Patients With Locally Advanced or Metastatic Biliary Tract Cancer GAMBIT Trial: Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer Study of TH-302 Monotherapy as Second-line Treatment in Advanced Biliary Tract Cancer Trial of Infusional FOLFIRINOX in First Line Treatment of Advanced Biliary Tract Cancers Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer Anlotinib in Combination With PD1 With Gemcitabine Plus(+)Cisplatin for Unresectable or Metastatic Biliary Tract Cancer Gemcitabine+ Capecitabine Vs Capecitabine in Curatively Resected Biliary Tract Cancer Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer A Study of Selective HDAC6 Inhibition With KA2507 in Advanced Biliary Tract Cancer Varlitinib Plus Capecitabine in Chinese Patients With Advanced or Metastatic Biliary Tract Cancer Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer Oral Rehydration Therapy for Short Hydration in Chemotherapy With CDDP Plus GEM for Biliary Tract Cancer A Study of RC48 in Subjects With HER2 Overexpressed Metastatic Biliary Tract Cancer. Case Series Study of Biliary Tract Cancer Patients in Japan GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer Molecular Profiling of Advanced Biliary Tract Cancers MEK162 in Combination With Capecitabine in Advanced Biliary Tract Cancer Allogeneic NK Cell (“SMT-NK”) in Combination With Pembrolizumab in Advanced Biliary Tract Cancer Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer Toripalimab Combined With S1 and Albumin Paclitaxel in Patients With Advanced Biliary Tract Cancer Vessel Resection and Reconstruction of Biliary Tract Cancers Apatinib as Second Line Therapy in Patients With Advanced Refractory Biliary Tract Cancers A Phase I Study of Adjuvant Chemotherapy With GS in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy A Phase II Trial of Preoperative Chemotherapy for Biliary Tract Cancer (BTC) With Node Metastasis A Phase I Study of Adjuvant Chemotherapy With GC in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC) NGS as the First-line Treatment in Advanced Biliary Tract Cancer Identification of Prognostic Gene Mutations in Biliary Tract Cancer Using Whole Genome Sequencing NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer Molecular Profiling of Advanced Biliary Tract Cancers

Brief Title

Camrelizumab Combined With Apatinib and Capecitabine in Patients With Advanced Unresectable Biliary Tract Cancer.

Official Title

Camrelizumab Combined With Apatinib and Capecitabine for Patients With Advanced Unresectable Biliary Tract Cancer: a Phase 2, Single-arm, Prospective Study.

Brief Summary

      Biliary tract cancer (BTC) is a series of rare malignancies with poor overall prognosis.
      Radical surgery the preferred treatment option, but most patients have lost the opportunity
      of surgery at the time of diagnosis. At present, there are limited systematical treatment
      options for biliary tract cancer, with poor efficacy and short duration of responses. In the
      past few years, immune checkpoint inhibitors (ICIs) therapy has gradually been added to the
      advanced biliary comprehensive treatment. However, in view of the low incidence and high
      heterogeneity of BTC, more large number of clinical trials and practices need to be carried
      out, and the effective combination regimens and predictive biomarkers need to be explored.
      This study is a single-arm, open-label, prospective cohort study, combining Camrelizumab with
      apatinib and capecitabine as the first-line or second-line treatment for patients with
      advanced biliary tract cancer. The study aims to explore the efficacy and safety of the
      combination regimen, and try to find biomarkers that can guild treatment. In this study, 34
      patients were enrolled by the Simon's two-stage design, with the objective response rate as
      the primary endpoint and the disease control rate, progression-free survival, overall
      survival and safety as secondary endpoints. It is expected that the three-drug combination
      regimen will have significant efficacy and manageable adverse reactions, and predictive
      biomarkers can be found.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Objective response rate

Secondary Outcome

 Disease Control Rates (DCR)

Condition

Biliary Tract Cancer

Intervention

Camrelizumab

Study Arms / Comparison Groups

 Camrelizumab combined with Apatinib and Capecitabine
Description:  Camrelizumab was administered 200mg iv every 3 weeks. Capecitabine was administered 1000mg/m2 orally, b.i.d. every 3 weeks (Day 1-14 of a treatment cycle) Apatinib:A safety-run-in was conducted in the first cycle to identify the recommended dose of Apatinib, the initial dose was administered 250mg orally daily every 3 weeks (Day 1-14 of a treatment cycle). The dose of Apatinib increase and reduction was 250 mg orally q.d. and 250 mg orally q.o.d. every 3 weeks respectively according to the number of doses limiting toxicity events (DLTs) in the initial group. The final dose of Apatinib for the extension stage was detemained by the result of safety-run-in stage.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

39

Start Date

February 1, 2021

Completion Date

August 1, 2023

Primary Completion Date

June 1, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Aged 18-70 years old, both genders.

          -  Conform to the histological or cytological confirmation of biliary tract
             carcinoma,including gallbladder cancers and cholangiocarcinomas.

          -  Patients have advanced unresectable biliary tract carcinoma, including recurrence or
             metastasis of BTC after radical resection.

          -  Patientss who have not received any prior PD-1 inhibitor and Apatinib therapy.

          -  Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria.

          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1within one week before
             enrollment.

          -  Life expectancy greater than 3 months.

          -  Patient must have adequate organ function defined by the study-specified laboratory
             tests.

          -  Patient must use acceptable form of birth control while on study.

          -  Ability to understand and willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Patients with known history of allogeneic organ transplantation or allogeneic
             hematopoietic stem cell transplantation or planned transplantation.

          -  Patients with other malignant tumor in the past 5 years (except cured skin basal cell
             carcinoma and cervical carcinoma).

          -  History of esophageal variceal bleeding, hepatic encephalopathy, massive ascites and
             abdominal infection.

          -  Concurrent medical condition requiring the use of immunosuppressive medications, or
             immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10
             mg/day prednisone or equivalent are prohibited within 14 days before study drug
             administration.

          -  Known history of hypersensitivity to any components of the camrelizumab, apatinib and
             Capecitabine formulation, or other antibody formulation.

          -  Patients who may receive live vaccine during the study, or previous had vaccination
             within 4 weeks.

          -  Known or occurrence of central nervous system (CNS) metastases or hepatic
             encephalopathy.

          -  Peripheral neuropathy> Grade 1.

          -  Patients with any active autoimmune disease or history of autoimmune disease.

          -  History of immunodeficiency or human immunodeficiency virus (HIV) infection.

          -  Clinically significant cardiovascular and cerebrovascular diseases, including but not
             limited to severe acute myocardial infarction within 6 months before enrollment,
             unstable or severe angina, or coronary artery bypass surgery, Congestive heart failure
             (New York heart association (NYHA) class > 2), ventricular arrhythmia which need
             medical intervention.

          -  Hypertension and unable to be controlled within normal level following treatment of
             anti-hypertension agents (within 3 months): systolic blood pressure > 140 mmHg,
             diastolic blood pressure > 90 mmHg.

          -  Coagulation abnormalities (INR>1.5 or APTT>1.5×ULN), with bleeding tendency or are
             receiving thrombolytic or anticoagulant therapy.

          -  History of hereditary or acquired bleeding and thrombotic tendency, such as
             hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc.

          -  Patients with obvious cough blood or hemoptysis volume of half teaspoon (2.5 ml) or
             more within 2 months before entering the study.

          -  Have significant clinically significant bleeding symptoms or have a clear bleeding
             tendency within 3 months before entering the study, such as gastrointestinal bleeding,
             hemorrhagic gastric ulcer, fecal occult blood++ and above at baseline, or vasculitis,
             etc.

          -  Previous Arterial/venous thrombosis events within 6 months.

          -  Required for long-term anticoagulant therapy with warfarin or heparin, or long-term
             antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day).

          -  Severe infection within 4 weeks before the first medication (e.g. need for intravenous
             antibiotics, antifungal or antiviral drugs), or active infection or an unexplained
             fever > 38.5°C during screening visits or on the first scheduled day of dosing.

          -  Participated in any other drug clinical study within 4 weeks before the first
             administration, or no more than 5 half lives from the last administration.

          -  Known history of psychotropic drug abuse or drug abuse.

          -  Pregnant and lactating women. Any other medical, psychiatric, or social condition
             deemed by the investigator to be likely to interfere with a subject's rights, safety,
             welfare, or ability to sign informed consent, cooperate, and participate in the study
             or would interfere with the interpretation of the results.
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Wei Deng, 8610-63138712, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04720131

Organization ID

BFH-BTC&PD-1


Responsible Party

Principal Investigator

Study Sponsor

Beijing Friendship Hospital


Study Sponsor

Wei Deng, Principal Investigator, Department of General Surgery, Beijing Friendship Hospital, Capital Medical University


Verification Date

January 2021