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).
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.
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;
Single group
Recaticimab and Adebrelimab
DrugPatients would receive Recaticimab (150 mg, sc., q4w) and Adebrelimab (1200 mg, iv., q3w) plus GP chemotherapy in 21day cycles. Recaticimab and Adebrelimab would be maintained until the disease progressed or intolerable toxicity and adverse reactions or the medication was used for two years.
GP chemotherapy
DrugGemcitabine/Cisplatin (gemcitabine 1000mg/m2 + cisplatin 25mg/m2) will be administered on D1/D8 in every three weeks cycle, up to 6 cycles.
objective response rate (ORR)
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
Disease Control Rate (DCR)
DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator
Progression-Free Survival (PFS)
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Adverse Events (AE)
Overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.
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Sun Yat-sen University
Lead sponsor
Sun Yat-Sen University Cancer Center
Sponsor institution
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
