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

  • STATUS
    Recruiting
  • End date
    Nov 16, 2024
  • participants needed
    36
  • sponsor
    Sun Yat-sen University
Updated on 16 June 2022
platelet count
renal function
cancer
measurable disease
kidney function tests
metastasis
neutrophil count
gemcitabine
cholangiocarcinoma
unresectable intrahepatic cholangiocarcinoma

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.

Description

The trial will recruit 36 patients, and they will undergo radiotherapy plus anti-PD-1 antibody. Patients will receive conventional intensity-modulated radiotherapy or stereotactic body radiation therapy first for a total dose more than 45Gy. Camrelizumab 200mg intravenously every 3 weeks will be initiated within 7 days after radiotherapy.

Details
Condition Biliary Tract Cancer, Radiotherapy, Immunotherapy
Treatment Gemcitabine+Cisplatin, Radiotherapy+anti-PD-1, Radiotherapy+anti-PD-1 antibody
Clinical Study IdentifierNCT03898895
SponsorSun Yat-sen University
Last Modified on16 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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