Adjuvant Immunotherapy Combined With Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer

NCT ID: NCT04333927

Last Updated: 2020-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2024-06-30

Brief Summary

The study is a multicenter phase II randomized controlled trial. The purpose is to investigate the efficacy and safety of adjuvant immunotherapy combined with chemoradiation for patients with high-risk resectable extrahepatic cholangiocarcinoma and gallbladder cancer.

Detailed Description

The trial will recruit 92 patients, and they will be randomized (1:1) into two groups (chemoradiation+immunotherapy group, observation group) after operation. Patients in chemoradiation+immunotherapy group will receive camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal. After 1 or 2 courses of camrelizumab, patients went on to receive capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week) concurrent with radiotherapy (45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed). Patients in observation group will not receive any anti-cancer therapy.

Conditions

Biliary Tract Cancer; Extrahepatic Cholangiocarcinoma; Gallbladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Patients in treatment group will receive camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal. After 1 or 2 courses of camrelizumab, patients went on to receive capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week) concurrent with radiotherapy (45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed).

Group Type: EXPERIMENTAL

Chemotherapy

Intervention Type: DRUG

Capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week).

Immunotherapy

Intervention Type: PROCEDURE

Camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal.

Radiotherapy

Intervention Type: RADIATION

45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed.

Observation

Patients in observation group will not receive any anti-cancer therapy.

Group Type: PLACEBO_COMPARATOR

Observation

Intervention Type: OTHER

Patients in observation group will not receive any anti-cancer therapy.

Interventions

Chemotherapy

Capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week).

Intervention Type: DRUG

Observation

Patients in observation group will not receive any anti-cancer therapy.

Intervention Type: OTHER

Immunotherapy

Camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal.

Intervention Type: PROCEDURE

Radiotherapy

45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Age: 18-70 years;

2. Primary resectable extrahepatic cholangiocarcinoma and gallbladder cancer proved by pathology which underwent radical surgery;

3. Pathology indicates R0 with T2-4 or N1; or R1;

4. ECOG PS 0-1;

5. Adequate hematologic, hepatic and renal function: ANC ≥ 1.5x10^9/L, Hb ≥ 80g/L, PLT ≥ 100 x10^9/L, albumin ≥ 28g/L, total bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN, CREA<1.5×ULN;

6. At least 6 months of life expectancy.

Exclusion Criteria

1. Pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial;

2. Received previous anti-cancer therapies;

3. With purulent, infected or delayed healed wounds;

4. Have risky bleeding events requiring transfusion, operation or local therapies, continuous medication in the past 3 months;

5. Have thromboembolism in the past 6 months, including myocardial infarction, unstable angina, stroke or transient ischemic attack, pulmonary embolism, deep vein thrombosis;

6. Have taken aspirin (>325mg/day) or other antiplatelet drugs continuously for 10 days or more within 2 weeks before enrolment;

7. Uncontrollable hypertension, systolic pressure>140mmHg or diastolic pressure>90mmHg after best medical care, or history of hypertensive crisis or hypertensive encephalopathy;

8. Symptomatic congestive heart failure (NYHA class II-IV). Symptomatic or badly-controlled arrhythmia. Congenital long QT syndrome or modified QTc>500ms upon screening;

9. Have active autoimmune diseases that require systemic treatment within 2 years before enrolment;

10. Active tuberculosis, having antituberculosis therapy at present or within 1 year;

11. Have a known history of prior invasive malignancies within 5 years before enrolment;

12. Have other uncontrollable comorbidities;

13. Infection of HIV, known syphilis requiring treatment;

14. Allergic to chemotherapeutics.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ming Kuang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Kuang, PhD

Role: STUDY_CHAIR

First Affiliated Hospital, Sun Yat-Sen University

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

References

Xiao H, Ji J, Li S, Lai J, Wei G, Wu J, Chen W, Xie W, Wang S, Qiao L, Tu J, Shen S, Peng Z. Adjuvant Chemoradiation and Immunotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Cancer: A Randomized Clinical Trial. JAMA Oncol. 2025 Sep 1;11(9):1021-1029. doi: 10.1001/jamaoncol.2025.1926.

Reference Type: DERIVED

PMID: 40638104 (View on PubMed)

Other Identifiers

BTC001

Identifier Type: -

Identifier Source: org_study_id