Clinical trial NCT04675983: A Study of Sintilimab Plus Ramucirumab as First-line Treatment for G/EGJ Adenocarcinoma (ORIENT-106)
Official title: A Randomized, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Sintilimab Combined With Ramucirumab as Compared to Chemotherapy for the First-line Treatment of Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (ORIENT-106)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gastric Adenocarcinoma
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Safety and tolerability of sintilimab plus ramucirumab,Overall survival (OS)
timeFrame: Randomization to Death from Any Cause, up to 60 months
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Randomization to Radiological Disease Progression or Death from Any Cause (Up to 24 Months)
measure: Objective Response Rate [ORR] (Percentage of Participants With Complete Response [CR] or Partial Response [PR])
timeFrame: Randomization to Disease Progression (Up To 24 Months)
measure: Disease Control Rate [DCR] (Percentage of Participants With Complete Response [CR], Partial Response [PR] or Stable Disease [SD])
timeFrame: Randomization to Disease Progression (Up To 24 Months)
measure: Duration of Response (DoR)
timeFrame: 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)
measure: Number of participants experiencing an adverse event (AE)
timeFrame: Randomization to end of study (up to 24 months)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
Study officials:
References: