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HAIC With Oxaliplatin, 5-FU and Bevacizumab Plus Intravenous Toripalimab for Advanced BTC | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

Hepatic Arterial Infusion Chemotherapy With Oxaliplatin, 5-fluorouracil and Bevacizumab Plus Intravenous Toripalimab for Advanced Biliary Tract Cancer

NCT04217954•Peking University

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 80 years

Sex

ALL

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:
+8 more criteria

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.
+9 more criteria

Locations (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

July 28, 2020

Primary Completion Date

May 19, 2023

Completion Date

June 1, 2023

Last Updated

June 23, 2023

Enrollment

ACTUAL participants

Conditions

Advanced Biliary Tract Cancer

Interventions

OXA, 5-FU and bevacizumab plus Toripalimab

DRUG

NGS as the First-line Treatment in Advanced Biliary Tract Cancer

NCT04172402

Advanced Biliary Tract Cancer

View study

UNKNOWNPHASE2

Toripalimab Plus Lenvatinib as Second-line Treatment in Advanced Biliary Tract Cancers

NCT04211168

Advanced Biliary Tract Cancer

View study

TERMINATEDPHASE2

Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer

NCT01096745

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 23, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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