Status:
COMPLETED
A Study of the Efficacy and Safety of Chemotherapy Combined With Toripalimab in Advanced Biliary Tract Cancer
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
Shanghai Junshi Bioscience Co., Ltd.
OrigiMed
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
1. Target population: patients with advanced biliary tract cancer (including gallbladder carcinoma, intrahepatic and extrahepatic cholangiocarcinoma) . 2. Primary objective: progression free survival ...
Detailed Description
Backgrounds: Toripalimab (JS-001) is a PD-1 antibody developed by Shanghai Jun Shi Biomedical technology Co. Ltd. Nowadays, eighteen clinical trials of this drug have been conducted in patients with ...
Eligibility Criteria
Inclusion
- Male or female. Age ≥ 18 years and ≤75 years.
- histologically documented advanced biliary duct cancer, including gallbladder cancer, intrahepatic and extrahepatic cholangiocarcinoma, specimen within a year available for test (at least 10 pathological sections) .
- at least one measurable lesion in abdominal CT/MRI according to RESIST 1.1 is required.
- Karnofsky score≥ 80.
- Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L.
- Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \< 2.5 × ULN in the absence of liver metastases, or \< 5 × ULN in case of liver metastases. ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L.
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min.
- Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN.
- No serious concomitant disease that will threaten the survival of patients to less than 5 years.
- Written (signed) informed consent.
- Good compliance with the study procedures, including lab and auxiliary examination and treatment.
- Female patients should not be pregnant or breast feeding.
- Agree to take contraception measures during treatment and in 120 days after last dose of Toripalimab or in 180 days after last dose of chemo.
Exclusion
- history of chemo, radiation, immune therapy or radical resection for the biliary tract cancer, except those patients who relapsed after 6 months since the last time of adjuvant therapy.
- patients with active autoimmune disease or history of refractory autoimmune disease.
- patients with active malignant tumor in recent 2 years, except the tumor studied in this research or cured locally tumor like resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ.
- uncontrollable pleural effusion, pericardial effusion, or ascites in 2 weeks before recruitment.
- patients who have digestive tract bleeding in 2 weeks before recruitment or with high risk of bleeding.
- perforation / fistula of GI tract in 6 months before recruitment.
- losing over 20% body weight in 2 months before recruitment.
- pulmonary disease history: interstitial pulmonary disease, non-infective pneumonitis, pulmonary fibrosis, acute pulmonary disease.
- uncontrollable systemic diseases, including diabetes, hypertension, etc.
- severe chronic or active infections in need of systemic antibacterial, antifungal, or antiviral treatment, including TB or HIV, etc.
- patients with untreated chronic hepatitis B or HBV DNA over 500 IU/ml or positive HCV RNA.
- patients with any cardiovascular risk factors below:
- cardiac chest pain occurring in 28 days before recruitment, defined as moderate pain that limits daily activity.
- pulmonary embolism with symptoms occurring in 28 days before recruitment.
- acute myocardial infarction occurring in 6 months before recruitment.
- any history of heart failure reaching grade 3/4 of NYHA in 6 months before recruitment.
- ventricular arrhythmias of Grade 2 or grater in 6 months before recruitment, or accompanied by supraventricular tachyarrhythmias requiring medical treatment.
- cerebrovascular accident within 6 months before recruitment.
- patients with peripheral neuropathy NCI CTC AE grade 1, except those with only deep tendon reflex disappearing.
- moderate or severe renal injury \[creatinine clearance rate≤50 ml/min (according to Cockroft \& Gault equation)\], or Scr\>ULN.
- allergic to any drug in this study.
- history of allogeneic stem cell transplantation or organ transplantation.
- use of steroids (dosage\>10mg/d prednisone) or other systemic immune suppressive therapy in 14 days before recruitment, except patients treated with regimens below: a. steroids for hormone replacement (dosage\>10mg/d prednisone); b. steroids for local application with little systemic absorption; c. short -term (≤ 7 days) steroids for preventing allergy or vomiting.
- vaccinated with live vaccine in 4 weeks before recruitment.
- receiving immune (interleukin, interferon, thymin) treatment or treatment of other trials in 28 days before recruitment.
- receiving palliative radiation in 14 days before recruitment.
- history of anti PD-1, PD-L1, PD-L2 or any other specific T cell co-stimulation or checkpoint pathway targeted treatment.
- receiving operation in 28 days before recruitment, only if the operation is a minimally invasive one e.g. PICC.
- for patients with uncontrolled epilepsy, CNS diseases or history of mental disorder, researchers should evaluate whether their diseases will impede their signing of informed consent or compliance of treatment.
- existing of potential situation which will impede drug administration or affect toxicity analysis or alcohol/ drug abuse.
Key Trial Info
Start Date :
December 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03796429
Start Date
December 17 2018
End Date
March 30 2022
Last Update
November 29 2023
Active Locations (1)
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1
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200032