SHR-1210 Combined With Apatinib Mesylate in the Perioperative Treatment of Hepatocellular Carcinoma (HCC-009)
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|ClinicalTrials.gov Identifier: NCT04297202|
Recruitment Status : Recruiting
First Posted : March 5, 2020
Last Update Posted : August 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Apatinib Combined With SHR-1210 Injection||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-label, Single Arm, Investigator-initiated Trail of An Anti-PD-1 Inhibitor SHR-1210 in Combination With Apatinib in the Perioperative Treatment of Hepatocellular Carcinoma|
|Actual Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Experimental: Apatinib Combined With SHR-1210 Injection
SHR-1210 Injection: 3 cycles of neoadjuvant therapy before surgery, two weeks is a treatment cycle; Apatinib : D1-D21 : 250 mg, orally, qd; Before surgery, the patient's surgical pathology samples still need to be collected.
D46 : Patients were preoperatively evaluated. Operable patients were scheduled for hepatectomy with/without microwave ablation;
After 4 to 8 weeks after liver resection, a postoperative adjuvant program is performed. The cycle of a three-week plan will be performed with a total of 8 cycles with the treatment of Apatinib combination with SHR-1210 Injection.
Drug: Apatinib Combined With SHR-1210 Injection
3 cycles of neoadjuvant therapy before surgery, two weeks is a treatment cycle: D1、D15、D31 : SHR-1210 200mg, I.V, q2w； D1-D20 : Apatinib 250 mg, orally, qd; D46 : Patients were preoperatively evaluated. Operable patients were scheduled for hepatectomy with/without microwave ablation; After 4 to 8 weeks after liver resection, a postoperative adjuvant program is performed. Three weeks is a treatment cycle with a total of 8 cycles
In each cycle:
D1: SHR-1210 200mg, I.V, q3w; D1-D21: Apatinib 250mg, orally, qd;
- Major pathologic response [ Time Frame: 6 months ]It is defined as residual tumors less than 10% after neo-adjuvant therapy
- Pathological complete response [ Time Frame: 6 months ]No histologic evidence of malignancy or only the ingredients of carcinoma in situ was found in primary tumors
- Objective Response(ORR) [ Time Frame: Before surgery； ]It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR.
- Recurrence free survival(RFS) [ Time Frame: through study completion, an average of 1 year ]from surgery to relapse or death resulting from any cause .
- Recurrence free survival rates of 6 months and 12 months [ Time Frame: 12 months ]the rate of proportion of all patients from surgery to relapse or death resulting from any cause.
- Overall survival rate (6 m or 12 m) [ Time Frame: through study completion; the rate of OS for 6 months and 12 months ]It is defined as the time from randomization to death from any cause during the course of the study
- Safety as measured by the rate of AEs [ Time Frame: through study completion, an average of 1 year ]Safety will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 4.0.3
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04297202
|Contact: Xuehao Wang||86-025-68303211||Wangxh@njmu.edu.cn|
|Jiangsu Province Hospital||Recruiting|
|Nanjing, Jiangsu, China, 210029|
|Contact: Xuehao Wang 86-025-68303211 firstname.lastname@example.org|
|Study Chair:||Xuehao Wang||The First Affiliated Hospital with Nanjing Medical University|