biliary tract cancers,BTCs
Conditions
Interventions
First-line treatment group:paromlimab and Tuvonralimab Injection:5mg/kg, on day 1 , day 21 of each cycle
Gemcitabine: 1000mg/m2, IV, d1, d8, Q3W (no maximum cycles of use)
Cisplatin: 25mg/m2.
Second-line treatment group:paromlimab and Tuvonralimab Injection:5mg/kg, on day 1 , day 21 of each cycle
Chemotherapy: investigator-determined
Sponsors
Huaibei People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent form prior to any trial-related procedures. 2. Age >=18 years, regardless of gender. 3. Histologically confirmed unresectable locally advanced or metastatic biliary tract malignancies, including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, distal cholangiocarcinoma, and gallbladder carcinoma. 4. First-line cohort: No prior systemic therapy. For recurrent patients, >6 months must have elapsed since curative surgery or neoadjuvant therapy. Second-line cohort: At least one prior systemic therapy. Patients who received adjuvant/neoadjuvant chemotherapy (one regimen) with disease progression within 6 months are considered to have received one systemic therapy. Patients who completed last dose of approved anti-tumor traditional Chinese medicine (with oncology indications) at least 2 weeks prior are eligible. 5. At least one measurable lesion confirmed by the investigator per RECIST 1.1. 6. ECOG performance status of 0-2. 7. For females of childbearing potential, patient and/or partner agrees to use highly effective contraception. 8. Expected survival >=3 months. 9. Hepatitis B (HBV) patients meeting the following criteria are eligible: a) HBV viral load =1.5×10?/L. b) Platelets >=75×10?/L. c) Hemoglobin >=90 g/L. d) Serum albumin >=30 g/L. e) AST/ALT 1.5×ULN, creatinine clearance (CLcr) calculated by Cockcroft-Gault equation >=50 mL/min. h) Left ventricular ejection fraction (LVEF) >50%. i) Proteinuria <2+ (if =2+, 24-hour urine protein <=1g required). j) INR <=1.5; APTT <=1.5×ULN. 12. Patients deemed likely to benefit by the investigator.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of ampullary carcinoma. 2. History of other malignancies within 5 years prior to signing informed consent (except cured basal cell skin cancer, papillary thyroid carcinoma, etc.). 3. Systemic infection requiring intravenous antibiotics >7 days within 2 weeks before first dose, or unexplained fever >38.5°C during screening/pre-enrollment (fever attributed to tumor progression by investigator’s judgment is excluded). 4. Active or potentially recurrent autoimmune disease; diagnosed immunodeficiency; or systemic corticosteroid therapy/immunosuppressive therapy/immunomodulatory agents within 7 days prior to first dose. 5. Symptomatic central nervous system (CNS) metastases. 6. Subjects with severe cardiovascular disease; 7. Interstitial lung disease, pneumoconiosis, radiation pneumonitis (clinically significant per investigator), severe pulmonary dysfunction, or conditions interfering with detection/management of drug-related pulmonary toxicity. 8. HIV-positive; active tuberculosis within 1 year prior to treatment; active syphilis infection. 9. Major surgery within 1 month before first dose, or active ulcers/unhealed wounds (excluding central venous catheterization, tumor biopsy, or nasogastric tube placement). 10. History of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplants). 11. Administration of live vaccines within 4 weeks prior to first dose. 12. Participation in other clinical trials with investigational drugs within 4 weeks prior to first dose. 13. History of substance abuse, alcoholism, or drug addiction; or neurological/psychiatric disorders (e.g., epilepsy, dementia, hepatic encephalopathy). 14. Contraindications or allergies to any component of the investigational drug. 15. Pregnant or lactating women. 16. Patients deemed ineligible by the investigator due to risks or interference with study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Control Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival;Disease Control Rate;Duration of Response;Adverse Events; | — |
Countries
China
Contacts
Public ContactWenkai Du
Huaibei People's Hospital
Outcome results
None listed