Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC

Gastric Cancer Clinical Trial

Official title:

A Study of Camrelizumab (SHR-1210) Combined With Apatinib Versus Paclitaxel or Irinotecan in Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma Progressed After First-line Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04342910
• Other study ID #: SHR-1210-III-316
• Status: Recruiting
• Phase: Phase 3
• Start date: September 21, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: April 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Quanren Wang, Ph.D
• Phone: +862161053363
• Email: wangquanren[@]hrglobe.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line platinum-contained therapy. The primary study hypotheses are that camrelizumab (SHR-1210) combined with apatinib prolongs overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: September 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically- or cytologically-confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.

2. Confirmed metastatic or locally advanced, unresectable disease.

3. Progression on or after prior first-line therapy containing any platinum/fluoropyrimidine or platinum/taxane doublet.

4. Willing to provide tumor tissue for PD-L1 biomarker analysis.

5. Human epidermal growth factor receptor 2 (HER-2/neu) status known and participants with HER2/neu positive tumors show documentation of previous treatment containing trastuzumab.

6. ECOG performance status of 0 to 1.

7. Life expectancy of more than 12 weeks.

8. Signing the informed consent forms.

9. Adequate bone marrow, liver and renal function.

Exclusion Criteria:

1. Squamous cell or undifferentiated gastric cancer.

2. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

3. Subjects with an active, known or suspected autoimmune disease. Patients with type I diabetes who are receiving a stable dose of insulin, hypothyroidism who only needs hormone replacement therapy, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and do not have acute deterioration within 1 year before the screening period, are allowed.

4. Clinically significant cardiovascular and cerebrovascular diseases.

5. Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.

6. Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.

7. Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first 6 months of randomization.

8. Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.

9. Prior systemic chemotherapy, radiotherapy and surgery within 4 weeks before the study drug administration, or any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• camrelizumab
200 mg intravenous (IV) camrelizumab on Day 1 and Day 15 of each 28-day cycle.
• Apatinib Mesylate
250 mg qd
• Paclitaxel
80 mg/m^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
• Irinotecan
180 mg/m^2 administered as IV infusion on Days 1, and 15 of each 28-day cycle.

Locations

Country	Name	City	State
China	Affiliated Hospital, Academy of Military Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS) in PD-L1 Positive Participants.	OS was defined as the time from randomization to death due to any cause.	Up to 27 months
Secondary	Overall Survival (OS) in All Participants.	OS was defined as the time from randomization to death due to any cause.	Up to 27 months
Secondary	Progression-free Survival (PFS) According to RECIST 1.1 base on investigator assessment in All Participants or in PD-L1 Positive Participants.	PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first.	Up to 27 months
Secondary	Time to Tumor Progression (TTP) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.	TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment in All Participants.	Up to 27 months
Secondary	Time to Failure (TTF) in All Participants or in PD-L1 Positive Participants	TTF was defined as the time from randomization to treatment discontinuation caused by any reason.	Up to 27 months
Secondary	Objective Response Rate (ORR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.	ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to RECIST 1.1 based on investigator assessment.	Up to 27 months
Secondary	Duration of Response (DOR) According to RECIST 1.1 Based on investigator assessment in All Participants or in PD-L1 Positive Participants.	DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.	Up to 27 months
Secondary	Disease Control Rate (DCR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.	DCR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR or SD according to RECIST 1.1 based on investigator assessment.	Up to 27 months
Secondary	Time to Response (TTR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants.	TTR was defined as the time from randomization to the first documented evidence of CR or PR.	Up to 27 months
Secondary	The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03.	The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03.	Up to 27 months
Secondary	Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.	Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.	Up to 27 months
Secondary	Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline	Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline	Up to 27 months
Secondary	Serum concentration of camrelizumab	Serum concentration of camrelizumab	Up to 27 months
Secondary	Plasma concentration of apatinib	plasma concentration of apatinib	Up to 27 months