OncoMatch/Clinical Trials/NCT07636798
Hepatic Arterial Infusion Chemotherapy Plus Envafolimab and Lenvatinib for First-Line Unresectable Advanced Biliary Tract Cancer
Is NCT07636798 recruiting? Yes, currently enrolling (Jul 2026). This Phase 1/2 trial studies HAIC Combined Regimen Treatment Group for biliary tract cancer.
Treatment: HAIC Combined Regimen Treatment Group — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Demographics
Prior therapy
Cannot have received: immune checkpoint inhibitor
Lab requirements
Blood counts
absolute neutrophil count ≥ [missing value]/L; platelet count ≥ [missing value]; hemoglobin ≥ [missing value]
Kidney 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
Liver function
total bilirubin ≤ [missing value] × ULN; for patients without liver metastases, AST and ALT ≤ [missing value] × ULN; for patients with confirmed liver metastases, AST and ALT ≤ [missing value] × ULN
Cardiac function
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 LVEF < 40%
Adequate organ function to meet the criteria for chemotherapy: ... see full text for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07636798 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages