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

June 22, 2023 updated by: Xiaodong Wang, MD, Peking University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Peking University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OXA, 5-FU and Bev plus Toripalimab
the patients enrolled in this arm would receive hepatic arterial infusion chemotherapy with oxaliplatin, 5-fluorouracil and bevacizumab plus intravenous Toripalimab
Drug: OXA, 5-FU and bevacizumab plus Toripalimab

  1. concomitant treatment: A. HAIC: oxaliplatin (40 mg/m2 for 2 hours), 5-fluorouracil (800 mg/ m2 for 22 hours) on days 1-3, and arterial bevacizumab 300mg for 2 hours on d1 before oxaliplatin through a percutaneously implanted port-catheter system.

    B. Intravenous PD-1 inhibitor (Toripalimab) 240 mg for 30-60 minutes on d1 before the HAIC.

    The concomitant treatment repeat every three week, up to 6 cycles.

  2. Maintenance treatment: Bevacizumab (300mg) + PD-1 inhibitor (Toripalimab 240mg) will be given intravenously, every 3 weeks.
Other Names:
  • FOLFOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: From the start of treatment until the end of treatment, up to approximately 3 years
CR plus PR according to imRECIST
From the start of treatment until the end of treatment, up to approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From the start of treatment until death or lost to follow-up, up to approximately 3 years
date from the start of treatment until death or lost to follow-up, whichever happen first, assessed at least 6 months
From the start of treatment until death or lost to follow-up, up to approximately 3 years
Adverse events
Time Frame: From the start of treatment until the end of treatment, up to approximately 3 years
type and incidence of adverse events
From the start of treatment until the end of treatment, up to approximately 3 years
Progression-free survival
Time Frame: From the start of the treatment until first documented progression or death from any cause, whichever came first, assessed up to approximately 3 yearsse date of disease progression
date from the first treatment to the date of disease progression, lost to follow-up or death, whichever happen first
From the start of the treatment until first documented progression or death from any cause, whichever came first, assessed up to approximately 3 yearsse date of disease progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Investigators

  • Study Director: Xiaodong Wang, MD, Department of Interventional Therapy, Peking University Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2020

Primary Completion (Actual)

May 19, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

January 1, 2020

First Submitted That Met QC Criteria

January 3, 2020

First Posted (Actual)

January 6, 2020

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIBTC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

signed informed consent with patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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