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

Gastric Adenocarcinoma Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04675983
• Other study ID #: CIBI308E302
• Status: Terminated
• Phase: Phase 3
• Start date: March 10, 2021
• Est. completion date: February 12, 2023

Study information

• Verified date: February 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: February 12, 2023
• Est. primary completion date: February 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma

Intervention

Drug:
• Sintilimab
Administered IV
• Ramucirumab
Administered IV
• Cisplatin
Administered IV
• 5-fluorouracil
Administered IV
• Oxaliplatin
Administered IV
• Capecitabine
Administered orally

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-free Survival (PFS)	PFS is time from the date of randomization to the date of radiographic documentation of progression (per RECIST v.1.1) or the date of death due to any cause, whichever is earlier. If a participant is not known to have died or have radiographic documented progression as of the data cutoff date for the analysis, the PFS time is censored at the last adequate tumor assessment date.	Randomization to Radiological Disease Progression or Death from Any Cause (Up to 24 Months)
Secondary	Objective Response Rate [ORR] (Percentage of Participants With Complete Response [CR] or Partial Response [PR])	Response is defined using RECIST v1.1. ORR is calculated as sum of the number of participants with CR and PR divided by the number of evaluable participants multiplied by 100.	Randomization to Disease Progression (Up To 24 Months)
Secondary	Disease Control Rate [DCR] (Percentage of Participants With Complete Response [CR], Partial Response [PR] or Stable Disease [SD])	Response is defined using RECIST v1.1. DCR is calculated as sum of the number of participants with CR, PR, and SD divided by the number of evaluable participants multiplied by 100.	Randomization to Disease Progression (Up To 24 Months)
Secondary	Duration of Response (DoR)	DoR is time from the date of first radiographic documentation of CR or PR to the date of first radiographic documentation of PD or death due to any cause. If a participant is not known to have died or have radiographically documented PD as of the data inclusion cutoff date, DOR is censored at the date of the last adequate tumor assessment.	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)
Secondary	Number of participants experiencing an adverse event (AE)	An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. The number of participants who experienced an AE is reported for each arm according to the treatment received.	Randomization to end of study (up to 24 months)