HAIC With Oxaliplatin, 5-FU and Bevacizumab Plus Intravenous Toripalimab for Advanced BTC

Peking University

Status and phase: Completed; Phase 2

Conditions: Advanced Biliary Tract Cancer

Treatments: Drug: OXA, 5-FU and bevacizumab plus Toripalimab

Study type: Interventional

Funder types: Other

Identifiers

NCT04217954

FIBTC

Details and patient eligibility

About

Hepatic arterial infusion chemotherapy (HAIC) deliver high concentration of chemotherapeutic agents directly to the liver tumor, was proved to be effective for intrahepatic and perihilar cholangiocarcinoma. Based on the potential synergistic effect of bevacizumab, chemotherapy and PD-1 inhibitor, this phase II clinical study want to test the efficacy and safety using intra-arterial infusion of oxaliplatin, 5-fluorouracil and bevacizumab combined with intravenous infusion of PD-1 inhibitor (Toripalimab) in the treatment of unresectable biliary malignant tumors.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Biliary tract cancer proved by histology or cytology

2. Metastatic advanced or locally advanced unresectable biliary tract cancer, including gallbladder cancer, intrahepatic cholangiocarcinoma and perihilar cholangiocarcinoma, decided by hepatobiliary doctor and radiologist.

3. At least one measurable lesion within liver;

4. No prior intra-arterial/systemic chemotherapy or other systemic therapies

5. Prior resection, TACE or ablation will be allowed.

6. Age from 18 years old to 80 years old.

7. the performance of Eastern Cooperative Oncology Group (ECOG) <2

8. Child-Pugh A or Child-Pugh B (≤ score 7).

9. Expectant survival time ≥ 3 months.

10. Baseline blood count test and blood biochemical must meet following criteria:

    1. Hemoglobin ≥ 90 g/L;
    2. Absolute neutrophil count ≥ 1.5×10^9/L;
    3. Blood platelet count ≥ 100×10^9/L;
    4. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times of upper limit of normal (ULN);
    5. Total bilirubin ≤ 2 times of ULN;
    6. Serum creatinine ≤ 1.5 times of ULN;
    7. Albumin ≥ 30 g/L.

11. Patients sign informed consent.

Exclusion criteria

1. Distal cholangiocarcinoma.
2. Allergic to contrast agent.
3. Pregnant or lactational.
4. Allergic to 5-fluorouracil, or have metabolic disorder of 5-fluorouracil.
5. More than 80 years old.
6. Previous systematic chemotherapy or radiotherapy.
7. Child-Pugh C or Child-Pugh B (≥ score 8).
8. Coinstantaneous a lot of malignant hydrothorax or ascites.
9. History of organ transplantation (including bone marrow auto-transplantation and peripheral stem cell transplantation).
10. Coinstantaneous infection and need anti-infection therapy.
11. Hepatitis B virus DNA load ≥ 100 IU/ml (patients whose hepatitis B virus DNA load decreased to < 100 IU/ml after anti-virus therapy could be enrolled).
12. Coinstantaneous peripheral nervous system disorder or with history of obvious mental disorder and central nervous system disorder.
13. Diagnosed other kinds of malignant within 5 years, except for non-melanoma skin cancer and carcinoma in situ of cervix.
14. Without legal capacity.
15. Impact the study because of medical or ethical reasons.
16. Uncorrectable coagulation disorder.
17. Obvious abnormal in ECG or obvious clinical symptoms of heart disease, like congestive heart failure (CHF), coronary heart disease with obvious clinical symptoms, unmanageable arrhythmia and hypertension.
18. History of myocardial infarction within 12 months, or Grade III/IV of heart function.
19. Severe liver disease (like cirrhosis), renal disease, respiratory disease, unmanageable diabetes or other kinds of systematic disease.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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32 participants in 1 patient group

OXA, 5-FU and Bev plus Toripalimab

Experimental group

Description:

the patients enrolled in this arm would receive hepatic arterial infusion chemotherapy with oxaliplatin, 5-fluorouracil and bevacizumab plus intravenous Toripalimab

Treatment:

Drug: OXA, 5-FU and bevacizumab plus Toripalimab