COmbination of Radiotherapy With Anti-PD-1 Antibody for unREseCtable inTrahepatic Cholangiocarcinoma

• Status: Recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is a multicenter phase II randomized trial. The purpose is to investigate both the efficacy and safety of radiotherapy combined with anti-PD-1 antibody and chemotherapy (gemcitabine+cisplatin) in unresectable intrahepatic cholangiocarcinoma patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Antibodies; Cisplatin; Gemcitabine; Pembrolizumab

Criteria

Inclusion Criteria:

1. Age: 18-75 years;

2. Primary unresectable ICC or recurrent unresectable ICC following curative therapies proved by pathology;

3. No previous systemic chemotherapy or immunotherapy;

4. The volume of normal liver is larger than 700ml, eligible for radiotherapy, chemotherapy and immunotherapy after evaluation of specialized experts;

5. At least one measurable lesion based on RECIST 1.1 criteria;

6. Child-Pugh A class;

7. ECOG PS 0-1;

8. Adequate hematologic, hepatic and renal function: ANC ≥ 1.5x10^9/L, Hb ≥ 90g/L, PLT ≥ 100 x10^9/L, albumin ≥ 28g/L, total bilirubin < 1.5×ULN at diagnosis or after biliary drainage, ALT and AST < 5×ULN, BUN、CREA<1.5×ULN, creatinine clearance rate ≥ 45ml/min;

9. At least 12 weeks of life expectancy.

Exclusion Criteria:

1. 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;

2. Have metastasis in extrahepatic distant organs including lung, central nervous system, bone and etc. Or extrahepatic lymph node metastasis beyond abdomen;

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

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

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

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

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

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

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

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

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

12. Have other uncontrollable comorbidities;

13. Infection of HIV, known syphilis requiring treatment;

14. Allergic to elements of camrelizumab, gemcitabine or cisplatin.