Apatinib Plus Camrelizumab in Patients With Previously Treated Advanced Biliary Tract Cancer

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Brief Title

Apatinib Plus Camrelizumab in Patients With Previously Treated Advanced Biliary Tract Cancer

Official Title

Apatinib Plus Camrelizumab in Patients With Previously Treated Advanced Biliary Tract Cancer (ACABC): A Prospective Clinical Study

Brief Summary

      The investigators design a prospective clinical study to explore the efficacy and safety of
      apatinib plus camrelizumab in pretreated patients with advanced biliary tract malignant
      tumors and to analyze potential biomarkers of therapeutic response.
    

Detailed Description

      This was a non-randomized, single institutional, open-label, prospective trial designed to
      evaluate the efficacy and safety of apatinib in combination with camrelizumab for patients
      with biliary tract malignant tumors.

      It is estimated that 20 patients who met the study criteria will be enrolled in PUMCH and
      treated with aptinib and camrelizumab. The investigators will follow up and collect subjects'
      data each month to evaluate the efficacy and safety of treatment, including treatment related
      adverse events, overall survival and time to progression and objective response. Multi-omics
      data analysis will be used to find potential biomarkers of treatment response.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Progression-free Survival (PFS)

Secondary Outcome

 Overall Survival (OS)

Condition

Biliary Tract Cancer

Intervention

Apatinib plus Camrelizumab

Study Arms / Comparison Groups

 Apatinib plus Camrelizumab
Description:  Apatinib is a multi-target TKI, which selectively inhibits VEGFR-2.
Camrelizumabb is a anti-human PD-1 monoclonal antibody.

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

20

Start Date

December 1, 2018

Completion Date

December 1, 2021

Primary Completion Date

December 1, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Patients must have histologically or cytologically confirmed cholangiocarcinoma
             including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and
             gallbladder cancer. Patients with ampullary carcinoma are not eligible.

          2. Patients must have failed or are intolerant to one line of systemic chemotherapy
             treatment.

          3. Patients who received adjuvant chemotherapy and had evidence of disease recurrence
             within 6 months of completion of the adjuvant treatment are also eligible. If the
             patient received adjuvant treatment and had disease recurrence after 6 months,
             patients will only be eligible after failing or having intolerance to one line of
             systemic chemotherapy used to treat the disease recurrence.

          4. Age ≥ 18 years.

          5. Eastern Cooperative Oncology Group (ECOG) Performance Status Assessment of 0-2.

          6. Life expectancy of at least 12 weeks (3 months).

          7. Subjects must be able to understand and be willing to sign the written informed
             consent form. A signed informed consent form must be appropriately obtained prior to
             the conduct of any trial-specific procedure. Subjects must be willing and able to
             comply with scheduled visits, treatment schedule, laboratory testing, and other study
             requirements.

          8. All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1
             or less at the time of signing the Informed Consent Form (ICF) except for alopecia.

          9. For patients with advanced biliary tract cancer, liver function status Child-Pugh
             Class A or B (score<=7).

         10. Adequate bone marrow, liver and liver function as assessed by the following laboratory
             requirements: Total bilirubin ≤ 1.5 x the upper limits of normal (ULN), except for
             subjects with Gilbert Syndrome who can have bilirubin <3. Alanine aminotransferase
             (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with
             liver involvement of their cancer or stent placement). Alkaline phosphastase limit ≤
             2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer). Serum
             creatinine <2 x ULN. Hematologic parameters as follows: Platelet count ≥ 100,000 /mm3.
             Hemoglobin (Hb) ≥ 9 g/Dl. Absolute neutrophil count (ANC) ≥1000/mm. Blood transfusion
             to meet the inclusion criteria will be allowed.

         11. Women of childbearing potential must have a negative serum or urine pregnancy test
             (minimum sensitivity of 25 IU/L or equivalent units of HCG) performed within24 hours
             prior to the start of nivolumab Post-menopausal women (defined as no menses for at
             least 1 year) and surgically sterilized women are not required to undergo a pregnancy
             test.

         12. Subjects (men and women) of childbearing potential must agree to use adequate
             contraception beginning at the signing of the ICF until at least 3 months after the
             last dose of study drug. The definition of adequate contraception will be based on the
             judgment of the principal investigator or a designated associate.

         13. Patients with history of hepatitis B and hepatitis C will be eligible but patients
             with hepatitis B must be started on antiviral therapy prior to beginning study therapy

         14. Availability of archival tumor tissue for biomarkers analysis (FFPE block or cell
             block will be required). Specimen from primary site will be allowed. Patients must
             have at least 10 slides available. Repeat biopsy to obtain sufficient tissue for 10
             slides is allowed.

        Exclusion Criteria

          1. Subjects with active CNS metastases are excluded. If CNS metastases are treated and
             subjects are at neurologic baseline for at least 2 weeks prior to enrollment, they
             will be eligible but will need a Brain MRI prior to enrollment. Subjects must be off
             corticosteroids or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or
             equivalent).

          2. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo,
             type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only
             requiring hormone replacement, or conditions not expected to recur in the absence of
             an external trigger are permitted to enroll

          3. Subjects with a condition requiring systemic treatment with either corticosteroids
             (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14
             days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses
             > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune
             disease.

          4. Previous or concurrent cancer within 3 years prior to treatment start EXCEPT for
             curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial
             bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades
             lamina propria)].

          5. Known history of human immunodeficiency virus (HIV) infection or acquired
             immunodeficiency syndrome (AIDS).

          6. Child Pugh C disease

          7. History of severe hypersensitivity reactions to other monoclonal antibodies

          8. History of allergy or intolerance to study drug components or
             Polysorbate-80-containing infusions

          9. Substance abuse, medical, psychological or social conditions that may interfere with
             the patient's participation in the study or evaluation of the study results.

         10. History or concurrent condition of interstitial lung disease of any grade or severely
             impaired pulmonary function.

         11. Unresolved toxicity higher than CTCAE grade 1 attributed to any prior
             therapy/procedure excluding alopecia.

         12. Pregnant or breast-feeding patients. Women of childbearing potential must have a
             negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L or equivalent
             units of HCG) performed within 24 hours prior to the start of nivolumab and a negative
             result must be documented before start of treatment.

         13. Any illness or medical conditions that are unstable or could jeopardize the safety of
             the patient and his/her compliance in the study.

         14. Anticancer chemotherapy during the study or within 4 weeks of study enrollment.
             Subjects must have recovered from the toxic effects of the previous anti-cancer
             chemotherapy (with the exception of alopecia). Anti-cancer therapy is defined as any
             agent or combination of agents with clinically proven anti-tumor activity administered
             by any route with the purpose of affecting the malignancy, either directly or
             indirectly, including palliative and therapeutic endpoints.

         15. Hormonal therapy during the study or within 2 weeks of first study enrollment.

         16. Investigational drug therapy outside of this trial during or within 4 weeks of first
             study treatment.

         17. Notably, patients with severe esophageal varices or presented with positive fecal
             occult blood were also excluded.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Hai-Tao Zhao, M.D., +861069156042, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04642664

Organization ID

JS-2160


Responsible Party

Sponsor

Study Sponsor

Peking Union Medical College Hospital


Study Sponsor

Hai-Tao Zhao, M.D., Principal Investigator, Peking Union Medical College Hospital


Verification Date

November 2020