The Combination of Camrelizumab and Apatinib as Second-line Therapy for Advanced Pancreatic Carcinoma
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|ClinicalTrials.gov Identifier: NCT04415385|
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Camrelizumab Drug: Apatinib||Phase 2|
PD-1 antibody Camrelizumab is a humanized monoclonal antibody, and the heavy chain is immunoglobulin G4 (IgG4), the light chain is immunoglobulin κ (IgK). Camrelizumab specifically binds to PD-1 and blocks the interaction of PD-1 with its ligand (PD-L1), allowing T cells to recover against tumor immune responses.
Response rate, progression-free survival, overall survival, duration of response，disease control rate, drugs related side effects were recorded and analyzed, to assess the combination treatment could or couldn't benefit the patients with advanced pancreatic cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Combination of Camrelizumab and Apatinib as Second-line Therapy for Advanced Pancreatic Cancer Patients Who Failed Standard First-line Treatment: a Single Arm, Open-label, Phase 2 Study|
|Estimated Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||June 1, 2023|
Experimental: Camrelizumab + Apatinib
Participants receive Camrelizumab 200mg intravenously every 2 weeks and apatinib 250mg orally once daily until disease progression or unacceptable toxicity
200mg, intravenous infusion for 30 minutes (including the time of the tube, the overall infusion time is not shorter than 20 minutes, no longer than 60 minutes), once every 2 weeks.
Other Name: SHR-1210
250 mg, orally once a day. Take about half an hour after a meal with warm water.
Other Name: Apatinib Mesylate
- ORR [ Time Frame: Through study completion, an average of 2 years. ]ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- PFS [ Time Frame: Through study completion, an average of 2 years. ]Progression-free survival is defined as the duration from date of enrollment to the first occurrence of progression of disease or death from any cause
- OS [ Time Frame: Through study completion, an average of 2 years. ]Overall survival is defined as the duration from date of enrollment to the date of death from any cause.
- DoR [ Time Frame: Through study completion, an average of 2 years. ]DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
- DCR [ Time Frame: Through study completion, an average of 2 years. ]DCR is defined as the percentage of participants in the analysis population who have a CR, PR or stable disease (SD) per RECIST 1.1.
- Incidence of Adverse Events (AEs) in the treatment of Camrelizumab in combination with apatinib [ Time Frame: Through study completion, an average of 2 years. ]Number of participants with adverse events occurring up to 30 days after the last administration are evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0
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): NCT04415385
|Contact: Wangxia Lv, Masterfirstname.lastname@example.org|
|Zhejiang Cancer Hospital||Recruiting|
|Hangzhou, Zhejiang, China|
|Contact: Wangxia Lv, Master +8613757141026 email@example.com|