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The goal of this clinical trial is to explore the efficacy and safety of combined infusion chemotherapy with Adebrelimab and Apatinib in the perioperative treatment of resectable intrahepatic cholangiocarcinoma patients. The main question it aims to answer are:
How to improve the survival of patients with intrahepatic cholangiocarcinoma and prolong the recurrence time after surgery.
Participants will receive receive neoadjuvant therapy with Adebrelimab combined with apatinib and FOLFOX-HAIC for 2 cycles (1 treatment cycle every 21 days, apatinib only used for the first cycle), and surgery was performed 14-28 days after the end of treatment. After 28 days of surgery, patients will continue to receive adjuvant treatment with Adebrelimab combined with apatinib for a maximum of one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAIC+Adebrelimab+apatinib | Experimental | Neoadjuvant therapy with Adebrelimab combined with apatinib and FOLFOX-HAIC for 2 cycles (1 treatment cycle every 21 days, apatinib only used for the first cycle), and surgery was performed 14-28 days after the end of treatment. After 28 days of surgery, patients will continue to receive adjuvant treatment with Adebrelimab combined with apatinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAIC | Procedure | FOLFOX-hepatic artery infusion for 2 times. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response (pCR) | The proportion of subjects whose postoperative pathological examination did not detect residual cancer cells. | Up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Objective response rate | Up to one year |
| Event free survival (EFS) | The time from enrollment to the scheduled occurrence of events, including death, disease recurrence, disease progression, etc |
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Inclusion Criteria:
1. Pathological diagnosis as malignant tumor of Intrahepatic Cholangiocarcinoma;
2. According to the UICC/AJCC TNM staging system (8th edition, 2017), resectable subjects were classified as Ib-IIIb stages;
3. aged ≥ 18 years at the time of signing the Informed consent form (ICF);
4. Expected survival time>3 months;
5. Both men and women are eligible;
6. The patient's Eastern Oncology Collaborative Group (ECOG) physical condition score is 0 or 1;
7. No serious complications, such as hypertension, coronary heart disease, or history of mental illness, and no history of severe allergies; Non pregnancy and non lactation period;
8. The organ and blood system functions of the subjects meet the following requirements:
9. The subjects can understand and sign the informed consent form to participate in the experimental study; Good compliance.
10. Participants who have not undergone any local or systemic treatment for tumors in the past, and have undergone radical resection surgery for biliary tract cancer before recurrence for at least 2 years, can be included;
11. Subjects with potential fertility need to use a medically approved contraceptive measure (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and within one month after the end of the study treatment period; And within 72 hours before enrollment, the serum or urine HCG test must be negative and must be non lactating;
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Cancer Hospital and Institute | Recruiting | Jinan | Shandong | 250117 | China |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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| Adebrelimab |
| Drug |
Adebrelimab 1200mg, ivgtt, d1, q3w,up to one year of use at most. |
|
| Apatinib | Drug | Apatinib 250mg, po, qd,q3w,up to one year of use at most. |
|
| Up to two years |
| Overall Survival (OS) | Overall Survival:The survival time from enrollment to death from any cause. | Up to two years |
| Disease Control Rate (DCR) | Disease Control Rate: Ratio of complete response (CR)+partial response (PR)+stable disease (SD) | Up to one year |
| D009369 | Neoplasms |