About this trial
The study aims to evaluate the efficacy and safety of Recaticimab and Adebrelimab in Combination With chemotherapy in patients with metastatic biliary tract carcinoma (BTC).
Eligibility criteria
Qualifiers
1. Provided informed consent and sign the informed consent form;
2. Male or female, Aged 18-75 years (counted on the date of signing informed consent);
3. Histologically confirmed unresectable advanced or metastatic biliary tract adenocarcinoma, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.;
4. The patient is not a candidate for surgery, or the disease has progressed after prior surgery and/or local treatment.
Disqualifiers
1. Other active malignant tumor exceptBTCwithin 5 years or simultaneously. Cured localized tumor, for example, basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situs of cervix, breast cancer in situ may be enrolled;
2. A previous diagnosis of nephrotic syndrome, severe liver disease, Cushing's syndrome, or other diseases that significantly affect lipid levels; a history of low cholesterol, low lipidemia, or related family history, or a family history of allergy to PCSK inhibitors
3. Planning to or previously received organ or allogenic bone marrow transplantation;
4. Treatment of other investigational product(s) within 28 days prior to the start of study treatment;
Trial design
Treatments tested in this trial
- Recaticimab and Adebrelimab
- GP chemotherapy
Treatment groups
Locations
Sponsors and collaborators
Sun Yat-sen University
Lead sponsor
Sun Yat-Sen University Cancer Center
Sponsor institution
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborator