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Advanced Biliary Tract CancerPhase 2NCT04217954

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

A Phase 2 study testing OXA, 5-FU and bevacizumab plus Toripalimab in people with Advanced Biliary Tract Cancer, run by Peking University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Biliary Tract Cancer
What is being tested?
OXA, 5-FU and bevacizumab plus Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
28 Jul 2020to 1 Jun 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Biliary tract cancer proved by histology or cytology
  • Metastatic advanced or locally advanced unresectable biliary tract cancer, including gallbladder cancer, intrahepatic cholangiocarcinoma and perihilar cholangiocarcinoma, decided by hepatobiliary doctor and radiologist.
  • At least one measurable lesion within liver;
  • No prior intra-arterial/systemic chemotherapy or other systemic therapies
  • Prior resection, TACE or ablation will be allowed.
  • Age from 18 years old to 80 years old.
Show all 18Show fewer
  • the performance of Eastern Cooperative Oncology Group (ECOG) <2
  • Child-Pugh A or Child-Pugh B (≤ score 7).
  • Expectant survival time ≥ 3 months.
  • Baseline blood count test and blood biochemical must meet following criteria:
  • Hemoglobin ≥ 90 g/L;
  • Absolute neutrophil count ≥ 1.5×10^9/L;
  • Blood platelet count ≥ 100×10^9/L;
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times of upper limit of normal (ULN);
  • Total bilirubin ≤ 2 times of ULN;
  • Serum creatinine ≤ 1.5 times of ULN;
  • Albumin ≥ 30 g/L.
  • Patients sign informed consent.

Who cannot join

  • Distal cholangiocarcinoma.
  • Allergic to contrast agent.
  • Pregnant or lactational.
  • Allergic to 5-fluorouracil, or have metabolic disorder of 5-fluorouracil.
  • More than 80 years old.
  • Previous systematic chemotherapy or radiotherapy.
Show all 19Show fewer
  • Child-Pugh C or Child-Pugh B (≥ score 8).
  • Coinstantaneous a lot of malignant hydrothorax or ascites.
  • History of organ transplantation (including bone marrow auto-transplantation and peripheral stem cell transplantation).
  • Coinstantaneous infection and need anti-infection therapy.
  • 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).
  • Coinstantaneous peripheral nervous system disorder or with history of obvious mental disorder and central nervous system disorder.
  • Diagnosed other kinds of malignant within 5 years, except for non-melanoma skin cancer and carcinoma in situ of cervix.
  • Without legal capacity.
  • Impact the study because of medical or ethical reasons.
  • Uncorrectable coagulation disorder.
  • 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.
  • History of myocardial infarction within 12 months, or Grade III/IV of heart function.
  • Severe liver disease (like cirrhosis), renal disease, respiratory disease, unmanageable diabetes or other kinds of systematic disease.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: 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.

Being tested
OXA, 5-FU and bevacizumab plus Toripalimab
Keywords
hepatic arterial infusion chemotherapy, oxaliplatin, 5-fluorouracil, bevacizumab, Toripalimab, advanced biliary tract cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OXA, 5-FU and bevacizumab plus ToripalimabDrug

    Also called FOLFOX

    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.
    2. 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.
    3. Maintenance treatment: Bevacizumab (300mg) + PD-1 inhibitor (Toripalimab 240mg) will be given intravenously, every 3 weeks.
Study groups in NCT04217954
Study groupRoleWhat they receive
OXA, 5-FU and Bev plus ToripalimabExperimentalthe patients enrolled in this arm would receive hepatic arterial infusion chemotherapy with oxaliplatin, 5-fluorouracil and bevacizumab plus intravenous Toripalimab
Receives: Drug: OXA, 5-FU and bevacizumab plus Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

    CR plus PR according to imRECIST

    Measured: From the start of treatment until the end of treatment, up to approximately 3 years

Secondary outcomes (3)

  1. Overall survival

    date from the start of treatment until death or lost to follow-up, whichever happen first, assessed at least 6 months

    Measured: From the start of treatment until death or lost to follow-up, up to approximately 3 years

  2. Adverse events

    type and incidence of adverse events

    Measured: From the start of treatment until the end of treatment, up to approximately 3 years

  3. Progression-free survival

    date from the first treatment to the date of disease progression, lost to follow-up or death, whichever happen first

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2020
  2. Study start28 Jul 2020
  3. Primary completion19 May 2023
  4. Study completion1 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04217954
Sponsor's protocol ID
FIBTC
Status last verified
Jun 2023
First submitted
1 Jan 2020
Last updated
23 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: signed informed consent with patients

Publications

  • Park J, Kim MH, Kim KP, Park DH, Moon SH, Song TJ, Eum J, Lee SS, Seo DW, Lee SK. Natural History and Prognostic Factors of Advanced Cholangiocarcinoma without Surgery, Chemotherapy, or Radiotherapy: A Large-Scale Observational Study. Gut Liver. 2009 Dec;3(4):298-305. doi: 10.5009/gnl.2009.3.4.298. Epub 2009 Dec 31.

    PubMed 20431764

  • Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J; ABC-02 Trial Investigators. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010 Apr 8;362(14):1273-81. doi: 10.1056/NEJMoa0908721.

    PubMed 20375404

  • Boehm LM, Jayakrishnan TT, Miura JT, Zacharias AJ, Johnston FM, Turaga KK, Gamblin TC. Comparative effectiveness of hepatic artery based therapies for unresectable intrahepatic cholangiocarcinoma. J Surg Oncol. 2015 Feb;111(2):213-20. doi: 10.1002/jso.23781. Epub 2014 Sep 1.

    PubMed 25176325

  • Wang X, Hu J, Cao G, Zhu X, Cui Y, Ji X, Li X, Yang R, Chen H, Xu H, Liu P, Li J, Li J, Hao C, Xing B, Shen L. Phase II Study of Hepatic Arterial Infusion Chemotherapy with Oxaliplatin and 5-Fluorouracil for Advanced Perihilar Cholangiocarcinoma. Radiology. 2017 May;283(2):580-589. doi: 10.1148/radiol.2016160572. Epub 2016 Nov 7.

    PubMed 27820684

  • Gao F, Yang C. Anti-VEGF/VEGFR2 Monoclonal Antibodies and their Combinations with PD-1/PD-L1 Inhibitors in Clinic. Curr Cancer Drug Targets. 2020;20(1):3-18. doi: 10.2174/1568009619666191114110359.

    PubMed 31729943

  • Hegde PS, Wallin JJ, Mancao C. Predictive markers of anti-VEGF and emerging role of angiogenesis inhibitors as immunotherapeutics. Semin Cancer Biol. 2018 Oct;52(Pt 2):117-124. doi: 10.1016/j.semcancer.2017.12.002. Epub 2017 Dec 8.

    PubMed 29229461

  • Mathew M, Enzler T, Shu CA, Rizvi NA. Combining chemotherapy with PD-1 blockade in NSCLC. Pharmacol Ther. 2018 Jun;186:130-137. doi: 10.1016/j.pharmthera.2018.01.003. Epub 2018 Jan 31.

    PubMed 29352857

  • Dalgleish AG. Rationale for combining immunotherapy with chemotherapy. Immunotherapy. 2015;7(3):309-16. doi: 10.2217/imt.14.111.

    PubMed 25804482

  • Longo V, Brunetti O, Azzariti A, Galetta D, Nardulli P, Leonetti F, Silvestris N. Strategies to Improve Cancer Immune Checkpoint Inhibitors Efficacy, Other Than Abscopal Effect: A Systematic Review. Cancers (Basel). 2019 Apr 15;11(4):539. doi: 10.3390/cancers11040539.

    PubMed 30991686

  • Zheng K, Fu S, Zhu X, Cao G, Xu L, Liu P, Gao S, Xu H, Guo J, Chen H, Liu W, Xu D, Wang L, Yan X, Bao Q, Wu J, Wang K, Zhou J, Hao C, Xing B, Shen L, Yang R, Wang X. Phase II trial of hepatic arterial infusion chemotherapy plus bevacizumab and toripalimab for advanced biliary tract cancers: efficacy, safety, and exploratory analysis. Hepatobiliary Surg Nutr. 2026 Apr 1;15(2):37. doi: 10.21037/hbsn-24-463. Epub 2025 Feb 20.

    PubMed 41983220

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OXA, 5-FU and bevacizumab plus Toripalimab in people with Advanced Biliary Tract Cancer, run by Peking University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: From the start of treatment until the end of treatment, up to approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04217954, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.

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