A Study of SHR-1210 in Combination With Capecitabine + Oxaliplatin or Apatinib in Treatment of Advanced Gastric Cancer

NCT03472365 | Completed Phase 2 Results

• 1 other identifier: SHR-1210-II-207
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to estimate overall response rate (ORR) of SHR-1210 combined with capecitabine and oxaliplatin or with apatinib as first-line treatment in subjects with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Conditions

Gastric Cancer; GastroEsophageal Cancer

Keywords

PD-1; SHR-1210; Capecitabine; Oxaliplatin; Apatinib

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  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 RECIST 1.1.

  Up to approximately 6 months.

Secondary Outcomes (4)

• Progression-free Survival (PFS) Per RECIST 1.1

  Up to 24 months.

• Duration of Response (DOR) Per RECIST 1.1

  Up to 24 months.

• Disease Control Rate (DCR) Per RECIST 1.1

  Up to 24 months.

• Number of Subjects With Treatment-related Adverse Events (AEs)

  Up to 24 months.

Study Arms (2)

Cohort 1

EXPERIMENTAL

Participants receive SHR-1210 200 mg, intravenously (IV) every 3 weeks(Q3W) plus capecitabine 1000 mg/m\^2 twice daily (BID) by continuous oral administration for 14 days, followed by a recovery period of 7 days, plus oxaliplatin 130 mg/m\^2, IV q3w; for 4-6 cycles followed by SHR-1210 plus apatinib 375 mg PO qd if there is no PD.

Biological: SHR-1210; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Apatinib

Cohort 2

EXPERIMENTAL

Participants receive SHR-1210 200 mg, intravenously (IV) every 3 weeks(Q3W) plus apatinib 375 mg daily (QD) continuous oral administration of each 3-week cycle.

Biological: SHR-1210; Drug: Apatinib

Interventions

SHR-1210 BIOLOGICAL

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody

Also known as: Camrelizumab

Cohort 1; Cohort 2

Capecitabine DRUG

1000 mg/m\^2 administered as continuous oral twice daily (BID) of each 3-week cycle.

Cohort 1

Oxaliplatin DRUG

130 mg/m\^2 administered IV Q3W on Day 1 of each 3-week cycle.

Cohort 1

Apatinib DRUG

375 mg administered as continuous oral once daily (QD) of each 3-week cycle.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ).
• Age ≥ 18 years old, male or female.
• NO previous therapy for advanced/metastatic disease of GC/GEJ (including HER2 inhibitor). Subjects with previous adjuvant/neo-adjuvant therapy completed more than 6 months can be enrolled.
• Has measurable disease per RECIST 1.1.
• Life expectancy ≥ 12 weeks.
• Eastern Cooperative Group (ECOG) performance status of 0 to 1.
• Has adequate organ function.
• Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. If the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. And non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs.

You may not qualify if:

• Has known HER2-positive status.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or a VEGFR inhibitor.
• Has known active central nervous system metastases.
• Has received a live vaccine within 4 weeks prior to the first dose of study treatment.
• With any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
• Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention.
• Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg.
• Coagulation abnormalities (INR \> 1.5 or APTT \> 1.5×ULN), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• Peng Z, Wei J, Wang F, Ying J, Deng Y, Gu K, Cheng Y, Yuan X, Xiao J, Tai Y, Wang L, Zou J, Zhang Y, Shen L. Camrelizumab Combined with Chemotherapy Followed by Camrelizumab plus Apatinib as First-line Therapy for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. Clin Cancer Res. 2021 Jun 1;27(11):3069-3078. doi: 10.1158/1078-0432.CCR-20-4691. Epub 2021 Mar 25.

  PMID: 33766817 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

camrelizumab; Capecitabine; Oxaliplatin; apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Medical Director: Linna Wang
• Organization: Jiangsu Hengrui Pharmaceuticals Co., Ltd.

linna.wang@hengrui.com

+86-13581990612

Study Officials

• Lin Shen, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 21, 2018
• Study Start: April 2, 2018
• Primary Completion: November 25, 2020
• Study Completion: November 25, 2020
• Last Updated: January 11, 2024
• Results First Posted: January 11, 2024

Record last verified: 2023-04

Locations

CN (1)