A Phase I Study of Adjuvant Chemotherapy With GS in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy

Learn more about:
Related Clinical Trial
The Efficacy of Chemotherapy Combined With Immunocheckpoint Inhibitors in Advanced Biliary Malignancies Intestinal Microbiome, Oral Microbiome, and Whole Blood Transcriptome Analyses in Gastrointestinal Malignancies Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED) Study of SMT-NK Inj. Plus Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer RC48-ADC Combinatioed Envolizumab in Locally Advanced or Metastatic Biliary Tract Cancer With Positive HER-2 Envofolimab and Lenvatinib Combined With Gemcitabine Plus Cisplatin for Advanced BTC as First-Line Treatment(ENLIGHTEN) PT-112 (Phosplatin’s Platinum) Combine With Gemcitabine Injection for Advanced Solid Tumors An Open-label, Phase I/II Study of PLENA Regimen in Patients With Unresectable Pancreatic Cancer or BTC XmAb20717 in Advanced Biliary Tract Cancers Capecitabine Combined With Lenvatinib and Tislelizumab as Adjuvant Treatment After Resection in Patients With BTC. Palliadelic Treatment to Reduce Psychological Distress in Persons With Inoperable Pancreatobiliary Cancer Olaparib With or Without Durvalumab for DDR Gene Mutated Biliary Tract Cancer Following Platinum-based Chemotherapy Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies Phase II Trial of Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment Tislelizumab(Anti PD-1), Lenvatinib and GEMOX Transformation in the Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors 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

A Phase I Study of Adjuvant Chemotherapy With GS in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy

Official Title

A Phase I Study of Adjuvant Chemotherapy With Gemcitabine Plus S-1 in Patients With Biliary Tract Cancer Undergoing Curative Resection Without Major Hepatectomy

Brief Summary

      To decide maximum tolerated dose and recommended dose of treatment using gemcitabine plus S-1
      combination therapy in patients with biliary tract cancer undergoing resection without major
      hepatectomy
    

Detailed Description

      Surgery currently remains the only potentially curative treatment for biliary tract cancer
      (BTC), and most patients develop recurrence. Therefore, effective adjuvant chemotherapy is
      required to increase the curability of surgery and to prolong the survival in these patients.
      However, to date, no standard adjuvant chemotherapy has been established, and a guideline for
      BTC treatment recommends that trials of adjuvant chemotherapy be carried out.

      Recently, there are two reports about gemcitabine (GEM) + S-1 combination (GS)chemotherapy
      after surgical resection for patients with BTC. At Iwate Medical University, Takahara, et
      al., performed a phase I study using a regimen of repeating 28 days as 1 course. Patients
      received GEM on day 1 and day 15, and S-1 from day 1 to day 14. The recommended dose is 1,000
      mg/m² of GEM and S-1 80 mg/m² after a pancreatoduodenectomy. The 2-year survival rate of the
      34 patients that received the GS therapy was 78.6% (Cancer Chemother Pharmacol. 2012
      May;69(5):1127-33). At Hiroshima University, a cycle of chemotherapy consisted of intravenous
      GEM of 700 mg/m² on day 1 and oral S-1 of 50 mg/m² for 7 consecutive days, followed by a
      1-week break from chemotherapy (14days as 1 course). Fifty patients received GS therapy and
      had a significantly better 3-year survival rate (57%) compared with 53 cases of surgery alone
      (30%). The GS adjuvant chemotherapy was feasible and the adverse event was minimal (Ann Surg.
      2009 Dec;250(6):950-6).

      Thus, the regimens of these two studies were 14 or 28 days as 1 course. There was no regimen
      that consisted of GEM on day 1, 8 and S-1 for 14 consecutive days, followed by a 1-week break
      from chemotherapy (21days as 1 course), which is frequently used for unresectable BTC and
      pancreatic cancer.

      Though a hepatectomy is frequently performed during surgery for BTC, it is unclear if the
      effect of the anticancer agent is affected by a hepatectomy. Because GEM is metabolized by
      cytidine deaminase primarily in the liver, the ability to metabolize GEM after a hepatectomy
      is thought to decrease. Some clinical studies demonstrated that patients who had undergone a
      hepatectomy could not tolerate the standard dose and schedule of GEM. For adjuvant
      chemotherapy with GEM, it is necessary to separately examine whether or not the patient has
      undergone a hepatectomy.

      Considering these present conditions, we aimed to assess the safety and efficacy of GEM + S-1
      combination chemotherapy (21days as 1 course regimen, which is frequently used for
      unresectable BTC) for BTC with the patients undergoing curative resection without a
      hepatectomy.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Maximum tolerated dose

Secondary Outcome

 Number of Participants with dose limiting toxicity

Condition

Biliary Tract Cancer

Intervention

Gemcitabine, S-1

Study Arms / Comparison Groups

 gemcitabine , S-1
Description:  Level-2 Gem 800mg/msq, S-1 50mg/msq Level-1 Gem 800mg/msq, S-1 65mg/msq Level 1 Gem 1000mg/msq, S-1 65mg/msq Level 2 Gem 800mg/msq, S-1 80mg/msq

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

38

Start Date

April 2012

Completion Date

March 2017

Primary Completion Date

April 2015

Eligibility Criteria

        Inclusion Criteria:

          1. Biliary tract cancer (BTC) with more than stage IB

          2. BTC undergoing R0 or R1 resection without major hepatectomy

          3. Older than 20 years old

          4. PS 0 or 1

          5. No treatment other than surgery

          6. No dysfunction of main organs

          7. Possible oral intake

          8. Treatment start; after 4 weeks and within 12 weeks after surgery

          9. Obtained written informed consent

        Exclusion Criteria:

          1. Patients with resection of major hepatectomy

          2. Patients with double cancers

          3. Patients having severe allergy

          4. Patients with severe organ dysfunction

          5. Patients with active infectious disease

          6. Pregnancy

          7. Patients with severe psychological disease

          8. Patients seem inadequate for this study by investigators
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Hideyoshi Toyokawa, MD, PhD, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT01713387

Organization ID

KHBO1202

Secondary IDs

UMIN000007454

Responsible Party

Sponsor

Study Sponsor

Kansai Hepatobiliary Oncology Group


Study Sponsor

Hideyoshi Toyokawa, MD, PhD, Study Director, Kansai Medical University


Verification Date

August 2017