A Study of Sintilimab Plus Ramucirumab as First-line Treatment for G/EGJ Adenocarcinoma (ORIENT-106)

NCT04675983 | Terminated Phase 3

• 1 other identifier: CIBI308E302
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate the efficacy and safety of sintilimab plus ramucirumab compared to stand of care first-line chemotherapy in participants with advanced gastric or esophagogastric adenocarcinoma.

Conditions

Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of sintilimab plus ramucirumab,Overall survival (OS)

  OS is time from the date of randomization to the date of death from any cause. If the participant is alive at the cutoff for analysis (or was lost to follow-up), OS data is censored for analysis on the last date the participant is known to be alive.

  Randomization to Death from Any Cause, up to 60 months

Secondary Outcomes (5)

• Progression-free Survival (PFS)

  Randomization to Radiological Disease Progression or Death from Any Cause (Up to 24 Months)

• Objective Response Rate [ORR] (Percentage of Participants With Complete Response [CR] or Partial Response [PR])

  Randomization to Disease Progression (Up To 24 Months)

• Disease Control Rate [DCR] (Percentage of Participants With Complete Response [CR], Partial Response [PR] or Stable Disease [SD])

  Randomization to Disease Progression (Up To 24 Months)

• Duration of Response (DoR)

  Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 24 Months)

• Number of participants experiencing an adverse event (AE)

  Randomization to end of study (up to 24 months)

Study Arms (2)

Sintilimab + Ramucirumab

EXPERIMENTAL

Ramucirumab on days 1 and 8 in combination with Sintilimab on day 1 of each 21-day cycle until disease progression, intolerable toxicity or other criteria for treatment discontinuation

Drug: Sintilimab; Drug: Ramucirumab

Cisplatin+ 5-fluorouracil/Oxaliplatin+capecitabine

ACTIVE COMPARATOR

Cisplatin on day 1 in combination with 5-fluorouracil, continuous pumping for 24 hours a day on days 1 to 5 of each 21-day cycle. (FP regimen) or Oxaliplatin on day 1 in combination with capecitabine on days 1 to 14 of each 21-day cycle. (XELOX regimen)

Drug: Cisplatin; Drug: 5-fluorouracil; Drug: Oxaliplatin; Drug: Capecitabine

Interventions

Sintilimab DRUG

Administered IV

Also known as: Tyvyt, IBI308

Sintilimab + Ramucirumab

Ramucirumab DRUG

Administered IV

Also known as: LY3009806, IMC-1121B, Cyramza

Sintilimab + Ramucirumab

Cisplatin DRUG

Administered IV

Cisplatin+ 5-fluorouracil/Oxaliplatin+capecitabine

5-fluorouracil DRUG

Administered IV

Cisplatin+ 5-fluorouracil/Oxaliplatin+capecitabine

Oxaliplatin DRUG

Administered IV

Cisplatin+ 5-fluorouracil/Oxaliplatin+capecitabine

Capecitabine DRUG

Administered orally

Cisplatin+ 5-fluorouracil/Oxaliplatin+capecitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a histologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma
• With HER2 negative and PD-L1 positive tumor tissue
• Have fresh or archival tumor tissue samples within 6 months for PD-L1 expression test.
• Age ≥18 and ≤75 years
• Diagnosed as unresectable locally advanced or metastatic stage

You may not qualify if:

• Have received any prior palliative systemic treatment for advanced gastric or gastroesophageal junction adenocarcinoma.
• Known to have central nervous system metastases, cancerous meningitis, or bone metastases with a risk of paraplegia
• Known bone metastasis with a risk of paraplegia.
• Have any ascites that requires intervention.
• With bilateral medium pleural effusion or unilateral large pleural effusion leading to respiratory symptoms

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, China

Location

MeSH Terms

Interventions

sintilimab; Ramucirumab; Cisplatin; Fluorouracil; Oxaliplatin; Capecitabine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 19, 2020
• Study Start: March 10, 2021
• Primary Completion: February 12, 2023
• Study Completion: February 12, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-02

Locations

CN (1)