A Study of the Efficacy and Safety of Chemotherapy Combined With Toripalimab in Advanced Biliary Tract Cancer

NCT03796429 | Completed Phase 2 DMC

• 1 other identifier: JS001-ZS-BC001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Target population: patients with advanced biliary tract cancer (including gallbladder carcinoma, intrahepatic and extrahepatic cholangiocarcinoma) .
2. 2.Primary objective: progression free survival (PFS)/ overall survival (OS) of first-line chemotherapy plus PD-1 antibody (Toripalimab) in patients with advanced biliary tract cancer.
3. 3.objective response rate (ORR) of first-line chemotherapy plus PD-1 antibody (Toripalimab)
4. 4.safety of first-line chemotherapy plus PD-1 antibody (Toripalimab)

Conditions

Biliary Tract Cancer

Keywords

Advanced Biliary Tract Cancer; PD-1 antibody(Toripalimab); first-line chemotherapy

Outcome Measures

Primary Outcomes (2)

• progression free survival (PFS) of GS regimen plus PD-1 antibody (Toripalimab)

  PFS is defined as time interval from recruitment to tumor progression or censoring. Tumor progression is defined as below: 1) relapse of primary lesion 2) emerging of new lesion 3) distant metastasis 4) death of any reason 5)tumor progression according to RESIST 1.1 on CT/MRI.

  36 months after the last subject participating in

• overall survival (OS) of GS regimen plus PD-1 antibody (Toripalimab)

  OS is defined as time interval from recruitment to all-caused death or censoring.

  36 months after the last subject participating in

Secondary Outcomes (2)

• objective response rate (ORR) of GS regimen plus PD-1 antibody (Toripalimab)

  36 months after the last subject participating in

• Incidence of adverse Events of GS regimen plus PD-1 antibody (Toripalimab)

  1 month after the last date of treatment

Study Arms (1)

GS+Toripalimab

EXPERIMENTAL

Drug: GS+Toripalimab

Interventions

GS+Toripalimab DRUG

Patients will be given treatment as below once recruited: PD-1 antibody Toripalimab（240mg, iv, q3w），combined with GS regimen(gemcitabine 1000mg／m2 ，d1,d8 + S1 40-60mg bid\*14d，Q21d). The treatment will be continued until emerging of disease progression or intolerable adverse effects (The upper time limit for treatment is 2 years).

GS+Toripalimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Shanghai Junshi Bioscience Co., Ltd.: collaborator
• OrigiMed: collaborator

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Tianshu Liu, Doctor

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Medical oncology

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 8, 2019
• Study Start: December 17, 2018
• Primary Completion: December 1, 2021
• Study Completion: March 30, 2022
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

CN (1)