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This is an exploratory and prospective study, with the research subjects being patients with initially untreated and unresectable biliary tract tumors. The efficacy and safety of the treatment regimen consisting of Adebrelimab monoclonal antibody combined with targeted therapy and systemic chemotherapy were investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adebrelimab combined with the GC regimen and Apatinib | Experimental | Adebrelimab 1200mg, intravenous infusion, on day 1, repeated every 3 weeks; Gemcitabine 1000mg/m2, on days 1 and 8, every 3 weeks Cisplatin 50mg/m2, on day 1, every 3 weeks Apatinib 250mg, once daily, orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab combined with the GC regimen and Apatinib | Drug | Adebrelimab 1200mg, intravenous infusion, on day 1, repeated every 3 weeks; Gemcitabine 1000mg/m2, on days 1 and 8, every 3 weeks Cisplatin 50mg/m2, on day 1, every 3 weeks Apatinib 250mg, once daily, orally |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1. | At the end of Cycle 6 and 10 (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 18 months |
| PFS |
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Inclusion Criteria:
- 1. Pathological or histological diagnosis of malignant tumor of the biliary tract; 2. Patients who are classified as TxNx and TxNxM1 according to the UICC/AJCC TNM staging system (9th edition, 2024), and who, based on the judgment of the research team, meet the criteria for newly diagnosed incurable cases or are not suitable for surgery; 3. Age: 18-80 years old; 4. Expected survival period > 3 months; 5. Both genders are eligible; 6. ECOG PS score of 0 or 1; 7. No severe complications, such as hypertension, coronary heart disease, and history of mental illness, no severe allergy history; non-pregnant and non-lactating; 8. The patient's organ and hematological system functions meet the following requirements:
10. Newly diagnosed patients, who have not undergone any local or systemic treatment for the tumor in the past and have undergone radical resection surgery for biliary cancer, and whose disease recurs 2 years after the surgery can be included; 11. Patients with potential fertility should use a medically approved contraceptive method (such as intrauterine device, contraceptive pills, or condoms) during the study treatment and within 1 month after the end of the study treatment; and the serum or urine HCG test must be negative within 72 hours before the study enrollment, and must be non-lactating.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongjun Chen Yongjun Chen | Contact | 027-83662379 | yjchen@tjh.tjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
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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
| up to 24 months |
| 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 | up to 24 months |
| OS | Time from randomization to death from any cause | up to 24 months |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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