SHR-1210 in Combination With Apatinib in Patients With Metastatic, Persistent, or Recurrent Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT03816553|
Recruitment Status : Active, not recruiting
First Posted : January 25, 2019
Last Update Posted : November 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Cervical Carcinoma Metastatic Cervical Cancer||Drug: SHR-1210 Drug: Apatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SHR-1210, a Novel Anti-pd-1 Antibody, in Combination With Apatinib in Patients With Metastatic, Persistent, or Recurrent Cervical Cancer: a Single-arm, Open Label, Multi-center, Phase II Study|
|Actual Study Start Date :||January 19, 2019|
|Actual Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||August 1, 2021|
Experimental: SHR-1210 + Apatinib
Participants receive SHR-1210 200mg (3mg/kg for underweight patients) intravenously every 2 weeks and apatinib 250mg orally once daily until disease progression or unacceptable toxicity
SHR-1210 will be administered as a 30-minute IV infusion Q2W at a dose of 200mg (3mg/kg for underweight patients).
Other Name: Camrelizumab
Apatinib will be administered 250mg orally, once daily until progression.
Other Name: Apatinib Mesylate
- Objective Response Rate (ORR) [ Time Frame: Up to approximately 12 months ]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
- Progression-free Survival (PFS) [ Time Frame: Up to approximately 24 months ]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
- Overall survival (OS) [ Time Frame: Up to approximately 24 months ]Overall survival is defined as the duration from date of enrollment to the date of death from any cause.
- 6-month PFS rate [ Time Frame: From date of enrollment up to 6 months ]The rate of 6-month PFS
- 9-month OS rate [ Time Frame: From date of enrollment up to 9 months ]The rate of 9-month OS
- Duration of Response (DCR) [ Time Frame: Up to approximately 24 months ]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.
- Duration of Response (DOR) [ Time Frame: Up to approximately 24 months ]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.
- Incidence of Adverse Events (AEs) in the treatment of SHR1210 in combination with apatinib [ Time Frame: Up to approximately 24 months ]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 4.03.
- Impact of the treatment on Quality of Life (QOL) measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI) [ Time Frame: Baseline, every other cycle (each cycle is 28 days) and up to approximately 24 months ]The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. The score ranges 0-116 with a large score suggesting better QOL.
- Pain assessed by Brief Pain Inventory (BPI) [ Time Frame: Baseline, every other cycle (each cycle is 28 days) and up to approximately 24 months ]Single item from the BPI assessing "worst pain" in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score.
- PD-L1 expression on tumor and immune cells [ Time Frame: Up to approximately 24 months ]The efficacy of the combination of SHR-1210 and apatinib as measured by objective response, will be described in patients according to PD-L1 positive and PD-L1 negative.
- Tumor Mutation Burden (TMB) [ Time Frame: Up to approximately 24 months ]The impact of TMB on efficacy of the combination of SHR-1210 and apatinib will be explored.
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): NCT03816553
|Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Guangzhou Panyu Central Hospital|
|Guangzhou, Guangdong, China, 511400|
|The First affiliated Hospital of Sun Yat-sen University|
|Guanzhou, Guangdong, China, 510080|