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

NCT04333927 | Unknown Phase 2 DMC

• 1 other identifier: BTC001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Cancer; Extrahepatic Cholangiocarcinoma; Gallbladder Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.

  two years

Secondary Outcomes (2)

• Recurrence-free Survival

  two years

• Adverse Events

  two years

Study Arms (2)

Treatment

EXPERIMENTAL

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).

Drug: Chemotherapy; Procedure: Immunotherapy; Radiation: Radiotherapy

Observation

PLACEBO COMPARATOR

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

Other: Observation

Interventions

Chemotherapy DRUG

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

Treatment

Observation OTHER

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

Observation

Immunotherapy PROCEDURE

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

Treatment

Radiotherapy RADIATION

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

Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70 years;
• Primary resectable extrahepatic cholangiocarcinoma and gallbladder cancer proved by pathology which underwent radical surgery;
• Pathology indicates R0 with T2-4 or N1; or R1;
• ECOG PS 0-1;
• 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;
• At least 6 months of life expectancy.

You may not qualify if:

• Pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial;
• Received previous anti-cancer therapies;
• With purulent, infected or delayed healed wounds;
• Have risky bleeding events requiring transfusion, operation or local therapies, continuous medication in the past 3 months;
• Have thromboembolism in the past 6 months, including myocardial infarction, unstable angina, stroke or transient ischemic attack, pulmonary embolism, deep vein thrombosis;
• Have taken aspirin (\>325mg/day) or other antiplatelet drugs continuously for 10 days or more within 2 weeks before enrolment;
• Uncontrollable hypertension, systolic pressure\>140mmHg or diastolic pressure\>90mmHg after best medical care, or history of hypertensive crisis or hypertensive encephalopathy;
• Symptomatic congestive heart failure (NYHA class II-IV). Symptomatic or badly-controlled arrhythmia. Congenital long QT syndrome or modified QTc\>500ms upon screening;
• Have active autoimmune diseases that require systemic treatment within 2 years before enrolment;
• Active tuberculosis, having antituberculosis therapy at present or within 1 year;
• Have a known history of prior invasive malignancies within 5 years before enrolment;
• Have other uncontrollable comorbidities;
• Infection of HIV, known syphilis requiring treatment;
• Allergic to chemotherapeutics.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• 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.

  PMID: 40638104 DERIVED

MeSH Terms

Conditions

Biliary Tract Neoplasms; Cholangiocarcinoma; Gallbladder Neoplasms

Interventions

Drug Therapy; Observation; Immunotherapy; Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Methods; Investigative Techniques; Immunomodulation; Biological Therapy

Study Officials

• Ming Kuang, PhD

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 3, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 23, 2020

Record last verified: 2020-06

Locations

CN (1)