Status:
COMPLETED
Camrelizumab Combined With Apatinib and Capecitabine in Patients With Advanced Biliary Tract Cancer.
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
Biliary Tract Cancer
Anti-PD-1 Therapy
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04720131
Start Date
January 1 2021
End Date
May 30 2023
Last Update
January 30 2024
Active Locations (1)
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1
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050