AzTrials
AzTrials

Biliary Tract CancerPhase 1/2NCT07636798

Hepatic Arterial Infusion Chemotherapy Plus Envafolimab and Lenvatinib for First-Line Unresectable Advanced Biliary Tract Cancer

A Phase 1/2 study testing HAIC Combined Regimen Treatment Group in people with Biliary Tract Cancer, run by West China Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Advanced biliary tract cancer has a poor prognosis and limited efficacy with current regimens. This multicenter single-arm phase Ib/II trial explores the efficacy and safety of HAI-GP chemotherapy combined with intraoperative arterial envafolimab and lenvatinib as first-line therapy for unresectable BTC. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Biliary Tract Cancer
What is being tested?
HAIC Combined Regimen Treatment Group
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
Jun 2026to Dec 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all of the following inclusion criteria:
  • Age between 18 years and [missing value] years, inclusive.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Histologically or cytologically confirmed biliary tract carcinoma, deemed unsuitable for radical surgical resection.
  • At least one measurable lesion as determined by the investigator in accordance with mRECIST or RECIST version 1.1.
  • Estimated life expectancy greater than 3 months.
Show all 15Show fewer
  • No prior systemic therapy or local anti-tumor treatment, except for surgery (biliary drainage is permitted).
  • Patients who experience relapse more than 6 months after completion of postoperative adjuvant therapy may be enrolled.
  • Child-Pugh score of [missing value] points.
  • Adequate organ function to meet the criteria for chemotherapy:
  • Bone marrow function: absolute neutrophil count ≥ [missing value]/L; platelet count ≥ [missing value]; hemoglobin ≥ [missing value];
  • Hepatic function: total bilirubin ≤ [missing value] × upper limit of normal (ULN); for patients without liver metastases, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ [missing value] × ULN; for patients with confirmed liver metastases, AST and ALT ≤ [missing value] × ULN;
  • Renal function: serum creatinine ≤ [missing value] × ULN; routine urinalysis showing urinary protein < [missing value]; if baseline urinary protein is [missing value], a 24-hour urine collection must confirm total protein ≤ 1 g/24 h;
  • Coagulation function: international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; for patients receiving anticoagulant therapy, PT must be within the therapeutic range intended for the anticoagulant used.
  • Female patients must be postmenopausal or, if premenopausal, have a negative urine or serum pregnancy test; male patients must agree to use effective contraception or have undergone surgical sterilization during the trial and for 8 weeks following the final dose of the study drug.

Who cannot join

  • Patients meeting any of the following criteria will be excluded:
  • Known hypersensitivity to the investigational drug(s).
  • Current participation in another interventional clinical trial, or receipt of any investigational drug or use of investigational device within 4 weeks prior to first dosing.
  • History of malignancy outside the biliary tract within 5 years prior to first dosing, except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been completely resected.
  • Previous treatment with immune checkpoint inhibitors including anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).
  • History of solid organ or hematopoietic stem cell transplantation.
Show all 23Show fewer
  • Any condition requiring systemic corticosteroids (equivalent to prednisone or above) or other immunosuppressive therapy within 14 days prior to randomization.
  • Active autoimmune disease or history of autoimmune disease with potential for recurrence.
  • Radiographic evidence of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), or prior noninfectious pneumonitis identified on screening chest computed tomography (CT).
  • Severe infection within 4 weeks prior to randomization, including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia.
  • Severe chronic or active infection (including tuberculosis) requiring systemic (oral or intravenous) antibiotic therapy within 14 days prior to randomization.
  • Known history of Human Immunodeficiency Virus (HIV) infection (i.e., HIV-1/2 antibody positive); untreated active Hepatitis B. *Note: Subjects with Hepatitis B meeting the following criteria are eligible: HBV viral load < 2000 copies/mL (200 IU/mL) prior to the first dose, with anti-HBV therapy administered throughout the chemotherapy period to prevent viral reactivation. For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is necessary.* Patients with active Hepatitis C infection (HCV antibody positive and HCV-RNA above the lower limit of detection) are excluded.
  • Concurrent participation in another therapeutic clinical trial.
  • Presence of obstructive jaundice (enrollment permitted following active intervention such as biliary drainage or stenting and subsequent normalization of liver function).
  • Meeting any of the following cardiovascular criteria:
  • New York Heart Association (NYHA) Class II or higher heart failure within 3 months prior to initiation of study treatment;
  • Major cardiovascular events including myocarditis, myocardial infarction, cerebrovascular events, unstable arrhythmia, or unstable angina within 6 months prior to initiation of study treatment;
  • Symptomatic pulmonary embolism within [missing value] months prior to randomization;
  • Known artery disease or left ventricular ejection fraction (LVEF) < 40%.
  • Lactating women.
  • Women of childbearing potential unwilling to use contraception.
  • Vulnerable populations other than elderly or illiterate individuals, including those with mental illness, cognitive impairment, or critical illness.
  • Any other reason deemed by the investigator to render the subject unsuitable for study participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chang Liu, Doctor contact

18980606382

drliuchang@wchscu.cn

Ruihong Dai, Doctor contact

18715779637

760173632@qq.com

China1 site, 1 recruiting

  • Study Chair Liu Chang , West China Hospital, Chengdu, Sichuan 610041

    Chengdu, Sichuan, 610041

    Chang Liu, Doctor, 18980606382, drliuchang@wchscu.cn

    Ruihong Dai, Doctor, 18715779637, 760173632@qq.com

    Recruiting

Other trials in China

About this study

Official title: Safety and Efficacy of Hepatic Arterial Infusion Chemotherapy (GP Regimen) and Intra-arterial Infusion of Envafolimab Combined With Lenvatinib for Unresectable Advanced First-line Biliary Tract Cancer: A Multicenter, Phase Ib/II, Single-arm Clinical Study

Advanced biliary tract cancer has a poor prognosis and limited efficacy with current regimens. This multicenter single-arm phase Ib/II trial explores the efficacy and safety of HAI-GP chemotherapy combined with intraoperative arterial envafolimab and lenvatinib as first-line therapy for unresectable BTC. It conducts dose exploration to confirm the optimal dosage and evaluates clinical outcomes, aiming to establish a better comprehensive treatment strategy.

Being tested
HAIC Combined Regimen Treatment Group
Keywords
Biliary tract cancer, Phase I/II, Immunotherapy,, Lenvatinib, Envafolimab Injection, Hepatic arterial infusion,
Medical subject headings
Biliary Tract Neoplasms

What participants receive

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

  • HAIC Combined Regimen Treatment GroupDrug

    In Phase Ib, nine patients will be enrolled and allocated to three dose cohorts to receive the combination regimen of HAIC (GP) + intra-arterial infusion of envafolimab + lenvatinib. Dose-limiting toxicities (DLTs) will be monitored for 28 days following administration. If no DLTs occur, the regimen will be considered tolerable, and patients will continue follow-up until 60 days post-administration. Investigators confirm Phase II initiation and optimal dose per safety data.

    In Phase II, 20 subjects adopt the optimized dose regimen. They firstly receive two cycles of combined treatment for efficacy evaluation. Those with clinical benefits finish six cycles in total, then switch to maintenance treatment until treatment ends, disease progresses, adverse reactions are intolerable, subjects withdraw consent or treatment is terminated by researchers. Robotic arm is applied to assist accurate hepatic artery catheterization and stable drug infusion during interventional procedures.

Study groups in NCT07636798
Study groupRoleWhat they receive
HAIC Combined Regimen Treatment GroupExperimentalIn Phase Ib, nine patients will be enrolled and allocated to three dose cohorts to receive the combination regimen of HAIC (GP) + intra-arterial infusion of envafolimab + lenvatinib. Dose-limiting toxicities (DLTs) will be monitored for 28 days following administration. If no DLTs occur, the regimen will be considered tolerable, and patients will continue follow-up until 60 days post-administration. Investigators confirm Phase II initiation and optimal dose per safety data. In Phase II, 20 subjects adopt the optimized dose regimen. They firstly receive two cycles of combined treatment for efficacy evaluation. Those with clinical benefits finish six cycles in total, then switch to maintenance treatment until treatment ends, disease progresses, adverse reactions are intolerable, subjects withdraw consent or treatment is terminated by researchers. Robotic arm is applied to assist accurate hepatic artery catheterization and stable drug infusion during interventional procedures.
Receives: Drug: HAIC Combined Regimen Treatment Group

What is being measured

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

  1. Primary endpoint for Phase Ib: Dose-Limiting Toxicity (DLT)

    The DLT observation period extends from the first dose to 28 days post-administration. If, among 9 patients enrolled in Phase Ib, the number experiencing DLT is ≤1 ，the dose level will be considered well tolerated; if the number is ≥2, dose reduction and re-evaluation will be required until a well-tolerated dose is established as the Recommended Phase II Dose (RP2D).

    Measured: Within 28 days after first dose (one safety observation cycle)

  2. Primary endpoint for Phase II:Objective Response Rate (ORR)

    Primary endpoint for Phase II:Objective Response Rate (ORR), defined as the proportion of patients achieving a predefined reduction in tumor volume maintained for the minimum required duration, including Complete Response (CR) and Partial Response (PR).

    Measured: Every 6 weeks (every two 21-day treatment cycles), up to completion of maximum six 21-day combination treatment cycles

Timeline

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

  1. First posted9 Jun 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionMar 2029 (estimated)
  4. Study completionDec 2029 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07636798
Sponsor's protocol ID
20261377
Status last verified
Jul 2026
First submitted
21 May 2026
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Jian Zhou FJ, Shi Guo-Ming, et al. . Gemox chemotherapy in combination with anti-PD1 antibody toripalimab and lenvatinib as first-line treatment for advanced intrahepatic cholangiocarcinoma: A phase 2 clinical trial. JOURNAL OF CLINICAL ONCOLOGY, 2021, 39(15_suppl):4094-4094 doi:10.1200/JCO.2021.39.15

  • Victoria Ruiz I, Uboha NV, Jamal R, Mejia FC, Ahumada M, Im SA, Gomez-Roca C, Shapira-Frommer R, Perets R, Yanez E, Dutcus C, Okpara CE, Ghori R, Jin F, Groisberg R, Castanon E. Lenvatinib Plus Pembrolizumab for Patients With Previously Treated Advanced Colorectal Cancer: Results From the Phase II LEAP-005 Study. Clin Colorectal Cancer. 2026 Jun;25(2):225-238.e2. doi: 10.1016/j.clcc.2026.01.003. Epub 2026 Jan 22.

    PubMed 41763955

  • Li J, Deng Y, Zhang W, Zhou AP, Guo W, Yang J, Yuan Y, Zhu L, Qin S, Xiang S, Lu H, Gong J, Xu T, Liu D, Shen L. Subcutaneous envafolimab monotherapy in patients with advanced defective mismatch repair/microsatellite instability high solid tumors. J Hematol Oncol. 2021 Jun 21;14(1):95. doi: 10.1186/s13045-021-01095-1.

    PubMed 34154614

  • Macarulla T, Ren Z, Chon HJ, Park JO, Kim JW, Pressiani T, Li D, Zhukova L, Zhu AX, Chen MH, Hack SP, Wu S, Liu B, Guan X, Lu S, Wang Y, El-Khoueiry AB. Atezolizumab Plus Chemotherapy With or Without Bevacizumab in Advanced Biliary Tract Cancer: Clinical and Biomarker Data From the Randomized Phase II IMbrave151 Trial. J Clin Oncol. 2025 Feb 10;43(5):545-557. doi: 10.1200/JCO.24.00337. Epub 2024 Oct 18.

    PubMed 39423355

  • Kelley RK, Ueno M, Yoo C, Finn RS, Furuse J, Ren Z, Yau T, Klumpen HJ, Chan SL, Ozaka M, Verslype C, Bouattour M, Park JO, Barajas O, Pelzer U, Valle JW, Yu L, Malhotra U, Siegel AB, Edeline J, Vogel A; KEYNOTE-966 Investigators. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 3;401(10391):1853-1865. doi: 10.1016/S0140-6736(23)00727-4. Epub 2023 Apr 16.

    PubMed 37075781

  • Valle JW, Lamarca A, Goyal L, Barriuso J, Zhu AX. New Horizons for Precision Medicine in Biliary Tract Cancers. Cancer Discov. 2017 Sep;7(9):943-962. doi: 10.1158/2159-8290.CD-17-0245. Epub 2017 Aug 17.

    PubMed 28818953

  • Chai Y. Immunotherapy of biliary tract cancer. Tumour Biol. 2016 Mar;37(3):2817-21. doi: 10.1007/s13277-015-4743-x. Epub 2016 Jan 4.

    PubMed 26729196

  • Mu MY, Chen ZX, Cao YZ, Fu XB, Qiu LJ, Qi H, Gao F. Transarterial chemoembolization combined with intra-arterial infusion of sintilimab and bevacizumab for advanced hepatocellular carcinoma: a phase 2 study. Cancer Lett. 2025 Sep 28;628:217851. doi: 10.1016/j.canlet.2025.217851. Epub 2025 Jun 3.

    PubMed 40472923

  • Shen L, Cao F, Liu Y, Nuerhashi G, Lin L, Tan H, Wen C, Wang Y, Chen S, Zou H, Xie L, Fan W. Hepatic artery infusion of FOLFOX chemotherapy plus camrelizumab combined with sorafenib for advanced hepatocellular carcinoma in Barcelona Clinic Liver Cancer stage C (Double-IA-001): a phase II trial. BMC Med. 2025 May 9;23(1):275. doi: 10.1186/s12916-025-04110-1.

    PubMed 40346494

  • Cai Z, He C, Zhao C, Lin X. Survival Comparisons of Hepatic Arterial Infusion Chemotherapy With mFOLFOX and Transarterial Chemoembolization in Patients With Unresectable Intrahepatic Cholangiocarcinoma. Front Oncol. 2021 Apr 1;11:611118. doi: 10.3389/fonc.2021.611118. eCollection 2021.

    PubMed 33868997

  • Cercek A, Boerner T, Tan BR, Chou JF, Gonen M, Boucher TM, Hauser HF, Do RKG, Lowery MA, Harding JJ, Varghese AM, Reidy-Lagunes D, Saltz L, Schultz N, Kingham TP, D'Angelica MI, DeMatteo RP, Drebin JA, Allen PJ, Balachandran VP, Lim KH, Sanchez-Vega F, Vachharajani N, Majella Doyle MB, Fields RC, Hawkins WG, Strasberg SM, Chapman WC, Diaz LA Jr, Kemeny NE, Jarnagin WR. Assessment of Hepatic Arterial Infusion of Floxuridine in Combination With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma: A Phase 2 Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):60-67. doi: 10.1001/jamaoncol.2019.3718.

    PubMed 31670750

  • Huang XY, Shi GM, Zheng ZT, Sun HC, Liang F, Ji Y, Chen Y, Yang GH, Hu ZQ, Lu JC, Meng XL, Guo XJ, Zhang CC, Fan J, Zhou J. Anti-PD1 antibody toripalimab combined with lenvatinib, or GEMOX chemotherapy combined with lenvatinib as first-line therapy in patients with advanced intrahepatic cholangiocarcinoma: a randomized, open, two-cohort Phase 2 Study. BMC Med. 2025 Oct 21;23(1):573. doi: 10.1186/s12916-025-04404-4.

    PubMed 41121202

  • Oh DY, He AR, Bouattour M, Okusaka T, Qin S, Chen LT, Kitano M, Lee CK, Kim JW, Chen MH, Suksombooncharoen T, Ikeda M, Lee MA, Chen JS, Potemski P, Burris HA 3rd, Ostwal V, Tanasanvimon S, Morizane C, Zaucha RE, McNamara MG, Avallone A, Cundom JE, Breder V, Tan B, Shimizu S, Tougeron D, Evesque L, Petrova M, Zhen DB, Gillmore R, Gupta VG, Dayyani F, Park JO, Buchschacher GL Jr, Rey F, Kim H, Wang J, Morgan C, Rokutanda N, Zotkiewicz M, Vogel A, Valle JW. Durvalumab or placebo plus gemcitabine and cisplatin in participants with advanced biliary tract cancer (TOPAZ-1): updated overall survival from a randomised phase 3 study. Lancet Gastroenterol Hepatol. 2024 Aug;9(8):694-704. doi: 10.1016/S2468-1253(24)00095-5. Epub 2024 May 29.

    PubMed 38823398

  • Eberlein TJ. Cisplatin plus Gemcitabine versus Gemcitabine for Biliary Tract Cancer. Yearbook of Surgery 2011;2011(310-312, doi:10.1016/s0090-3671(10)79889-x

  • Khan SA, Thomas HC, Davidson BR, Taylor-Robinson SD. Cholangiocarcinoma. Lancet. 2005 Oct 8;366(9493):1303-14. doi: 10.1016/S0140-6736(05)67530-7.

    PubMed 16214602

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HAIC Combined Regimen Treatment Group in people with Biliary Tract Cancer, run by West China Hospital 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 15 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Chang Liu, Doctor (18980606382, drliuchang@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary endpoint for Phase Ib: Dose-Limiting Toxicity (DLT) (time frame: Within 28 days after first dose (one safety observation cycle)). The study lists 2 primary outcomes in all. 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 NCT07636798, which also lists 19 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 13 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in