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NCT07599995

PHASE2

Gemcitabine-Cisplatin Plus Envafolimab in Resectable Biliary Tract Malignancies

Sponsor: Sir Run Run Shaw Hospital

View on ClinicalTrials.gov

Summary

This trial is to evaluate the efficacy of Gemcitabine-Cisplatin (GC) plus Envafolimab neoadjuvant therapy in the patients at high risk of recurrence. Primary endpoint: Major Pathologic Response (MPR). It will also learn about the safety of drug including Gemcitabine-Cisplatin (GC) plus Envafolimab as a neoadjuvant therapy in this trial.

Official title: The Efficacy and Safety of Gemcitabine-Cisplatin Plus Envafolimab as Neoadjuvant Therapy in Resectable Biliary Tract Malignancies at High Risk of Recurrence

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-05-30

Completion Date

2030-03-30

Last Updated

2026-05-20

Healthy Volunteers

Conditions

Biliary Tract Cancer

Interventions

DRUG

Neoadjuvant therapy followed by surgery

First: Envafolimab: 400 mg on Day 1, repeated every 3 weeks (Q3W). GC chemotherapy: Gemcitabine: 1000 mg/m2 in 100 mL of 0.9% sodium chloride injection, administered intravenously over 30 minutes on Days 1 and 8, repeated Q3W. Cisplatin: 25 mg/m2 in 500 mL of 5% glucose injection, administered intravenously over 2 hours on Day 1 and 8, repeated Q3W. Of note, no target drugs is involved. Second: Radical resection eligibility will be assessed by the investigator; those with indeterminate resectability require additional MDT discussion confirmation. The criteria for radical resection: 1. No invasion of the main trunk of the hepatic vein, portal vein, or inferior vena cava; 2. No distant metastasis except for hilar lymph node metastases; 3. Minimum distance between surgical margin and tumor border ≥ 0.5 cm; 4. Residual liver volume ≥ 30% (≥ 40% for participants with cirrhosis).

Inclusion Criteria: * Participants who have signed a written Informed Consent Form (ICF); * Male or female participants aged 18-80 years; * Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0/1; * Biliary Tract Cancer (BTC) diagnosed by puncture pathology prior to enrollment; * Participants must meet the following requirements for major vital organ function: a. Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; platelet count ≥ 90×10⁹/L; hemoglobin ≥ 9 g/dL; b. Coagulation function: international normalized ratio (INR) ≤ 1.2; c. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3 times the upper limit of normal (ULN); d. Serum albumin ≥ 3.5 g/dL; total bilirubin ≤ 1.5 times the ULN. Patients with obstructive jaundice who meet the eligibility criteria after percutaneous transhepatic cholangial drainage or endoscopic retrograde cholangiopancreatography treatment are also eligible for enrollment; e. Child-Pugh class A or B; f. Serum creatinine ≤ 1.5 times the ULN; * Patients with high-risk factors for recurrence. The criteria are defined as meeting at least one of the following: a. Preoperative CA19-9 ≥ 200 U/mL; b. Tumor diameter ≥ 5 cm or multiple tumor nodules on imaging; c. Regional lymph node metastasis with a short-axis diameter ≥ 1.0 cm on imaging; d. Vascular invasion (portal vein or hepatic artery) on imaging; e. Low or undifferentiated histologic grade; * Participants who have at least 1 measurable lesion (RECIST v1.1); * Be able to provide fresh stool samples and liver samples if undergoing surgery. Exclusion Criteria * Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma, and other non-cholangiocarcinoma malignant tumor components; * Prior systemic therapy for BTC, including immunotherapy, targeted therapy, or chemotherapy; * History of other prior or concurrent malignancies, except those with complete treatment and disease-free survival for more than 5 years; * Presence of an active, known or suspected autoimmune disease, or requirement for long-term systemic corticosteroid therapy (equivalent to ≥ 10 mg prednisone daily) or other immunosuppressive agents. Participants using inhaled or topical corticosteroids will not be excluded; * Presence of ascites, hepatic encephalopathy, sclerosing cholangitis, or other concurrent organ dysfunctions that would preclude tolerance of general anesthesia or hepatectomy; * Women who are breastfeeding or pregnant; * Any other factors that, in the investigator's judgment, may compromise participant safety or trial compliance, including serious comorbidities requiring ongoing treatment, clinically significant laboratory abnormalities, or relevant social or family-related issues.