COmbination of Radiotherapy With Anti-PD-1 Antibody for unREseCtable Biliary Tract Cancer

NCT03898895 | Unknown Phase 2 DMC

• 1 other identifier: BTC002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a single-arm, phase II trial. The purpose is to investigate both the efficacy and safety of radiotherapy combined with anti-PD-1 antibody in unresectable biliary tract cancer patients.

Conditions

Biliary Tract Cancer; Radiotherapy; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival, PFS

  defined as the time from the commencement of radiotherapy until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date of the last adequate tumor assessment. Patients not having an event will be censored at the date of the last adequate tumor assessment. If patients don't have baseline tumor assessments, they will be censored at the date of the first treatment.

  one years

Secondary Outcomes (4)

• Overall survival, OS

  one years

• Adverse events, AE

  one years

• Objective response rate, ORR

  one years

• Disease control rate, DCR

  one years

Study Arms (1)

Radiotherapy+anti-PD-1 antibody

EXPERIMENTAL

The total radiation dose is over 45Gy without damaging organic function. Conventional intensity-modulated radiotherapy or stereotactic body radiation therapy are both allowed. Camrelizumab 200mg intravenously every 3 weeks will be initiated within 7 days after radiotherapy. Patients will receive camrelizumab until clinical or radiographic disease progression, unacceptable toxicity, death or withdrawal. If disease progression is confirmed by radiologic examinations, another 200mg camrelizumab should be applied to the patient, then another radiologic examination will be performed 4 weeks later to confirm or exclude progression. If progression is confirmed, the camrelizumab should be stopped.

Combination Product: Radiotherapy+anti-PD-1 antibody

Interventions

Radiotherapy+anti-PD-1 antibody COMBINATION_PRODUCT

The total radiation dose is over 45Gy without damaging organic fucntion. Conventional intensity-modulated radiotherapy or stereotactic body radiation therapy are both allowed. Camrelizumab 200mg intravenously every 3 weeks will be initiated within 7 days after radiotherapy. Patients will receive camrelizumab until clinical or radiographic disease progression, unacceptable toxicity, death or withdrawal. If disease progression is confirmed by radiologic examinations, another 200mg camrelizumab should be applied to the patient, then another radiologic examination will be performed 4 weeks later to confirm or exclude progression. If progression is confirmed, the camrelizumab should be stopped.

Also known as: RT/IO

Radiotherapy+anti-PD-1 antibody

Eligibility Criteria

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

You may qualify if:

• Aged between 18 and 75 years old;
• Histopathologically confirmed unresectable primary or initial postoperative recurrent BTC without distant metastasis;
• No previous radiotherapy or systemic therapy;
• Adequate volume of the uninvolved liver (larger than 700 mL);
• At least one measurable lesion based on Response Evaluation Criteria in Solid Tumors 1.1 criteria;
• Eastern Cooperative Oncology Group performance status score of 0 or 1;
• Adequate hematologic (absolute neutrophil count ≥ 1.5x109/L, hemoglobin concentration ≥ 90g/L, platelet count ≥ 100 x109/L), hepatic (albumin ≥ 28 g/L, total bilirubin \< 1.5 times the upper limit of normal (ULN), alanine aminotransferase and aspartate aminotransferase \< 5×ULN) and renal function (serum creatine \< 1.5×ULN, creatinine clearance rate ≥ 45ml/min);
• Life expectancy of at least 12 weeks.

You may not qualify if:

• Have acute or chronic active hepatitis B or C, HBV-DNA\>2000IU/ml or 104 copy/ml; HCV-RNA\>103 copy/ml; both HBsAg and HCV antibody are positive. If the related results become lower than above standards after anti-viral treatment, the patients are qualified for enrolment;
• Have metastasis in extrahepatic distant organs including lung, central nervous system, bone and etc. Or extrahepatic lymph node metastasis beyond abdomen;
• 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;
• Pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial;
• Have other uncontrollable comorbidities;
• Infection of HIV, known syphilis requiring treatment;
• Allergic to elements of camrelizumab.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (1)

• Zhu M, Jin M, Zhao X, Shen S, Chen Y, Xiao H, Wei G, He Q, Li B, Peng Z. Anti-PD-1 antibody in combination with radiotherapy as first-line therapy for unresectable intrahepatic cholangiocarcinoma. BMC Med. 2024 Apr 19;22(1):165. doi: 10.1186/s12916-024-03381-4.

  PMID: 38637772 DERIVED

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Ming Kuang, PhD

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Ming Kuang, PhD

CONTACT

008687755766; kuangm@mail.sysu.edu.cn

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: Professor

Study Record Dates

• First Submitted: March 30, 2019
• First Posted: April 2, 2019
• Study Start: December 10, 2019
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)