Clinical Trials /

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

NCT04342910

Description:

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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Gastric Adenocarcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC
  • 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 IDs

  • ORG STUDY ID: SHR-1210-III-316
  • NCT ID: NCT04342910

Conditions

  • Gastric Cancer

Interventions

DrugSynonymsArms
camrelizumabSHR-1210camrelizumab (SHR-1210) combined with apatinib
Apatinib Mesylatecamrelizumab (SHR-1210) combined with apatinib
PaclitaxelPaclitaxel or Irinotecan
IrinotecanPaclitaxel or Irinotecan

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
camrelizumab (SHR-1210) combined with apatinibExperimentalParticipants will receive camrelizumab on Day 1 and Day 15 of each 28-day cycle and apatinib mg/day up to 2 years.
  • camrelizumab
  • Apatinib Mesylate
Paclitaxel or IrinotecanActive ComparatorParticipants receive paclitaxel on Days 1, 8, and 15 of each 28-day cycle, or irinotecan on Days 1 and 15 of each 28-day cycle.
  • Paclitaxel
  • Irinotecan

Eligibility Criteria

        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.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Survival (OS) in PD-L1 Positive Participants.
Time Frame:Up to 27 months
Safety Issue:
Description:OS was defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

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

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Jiangsu HengRui Medicine Co., Ltd.

Last Updated

April 10, 2020