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

Innovent Biologics

Status and phase: Terminated; Phase 3

Conditions: Gastric Adenocarcinoma

Treatments: Drug: Oxaliplatin; Drug: Sintilimab; Drug: Ramucirumab; Drug: Cisplatin; Drug: Capecitabine; Drug: 5-fluorouracil

Study type: Interventional

Funder types: Industry

Identifiers

NCT04675983

CIBI308E302

Details and patient eligibility

About

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.

Full description

This is a randomized, multicenter, phase 3 study to evaluate the efficacy and safety of sintilimab combined with ramucirumab as compared to stand of care chemotherapy for the first-line treatment of PD-L1 positive, unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

The primary endpoint of this study is OS of the ITT population.

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Sintilimab + Ramucirumab

Experimental group

Description:

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

Treatment:

Drug: Ramucirumab

Drug: Sintilimab

Cisplatin+ 5-fluorouracil/Oxaliplatin+capecitabine

Active Comparator group

Description:

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)

Treatment:

Drug: Cisplatin

Drug: Capecitabine

Drug: Oxaliplatin

Drug: 5-fluorouracil