Back to resultsA Study of Sintilimab Plus Ramucirumab as First-line Treatment for G/EGJ Adenocarcinoma (ORIENT-106)
Primary Purpose
Gastric Adenocarcinoma
Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Sintilimab
Ramucirumab
Cisplatin
5-fluorouracil
Oxaliplatin
Capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Adenocarcinoma
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
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sintilimab + Ramucirumab
Cisplatin+ 5-fluorouracil/Oxaliplatin+capecitabine
Arm 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
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)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04675983
First Posted
December 3, 2020
Last Updated
February 28, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04675983
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
February 12, 2023 (Actual)
Study Completion Date
February 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sintilimab + Ramucirumab
Arm Type
Experimental
Arm 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
Arm Title
Cisplatin+ 5-fluorouracil/Oxaliplatin+capecitabine
Arm Type
Active Comparator
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Other Intervention Name(s)
Tyvyt, IBI308
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Ramucirumab
Other Intervention Name(s)
LY3009806, IMC-1121B, Cyramza
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Safety and tolerability of sintilimab plus ramucirumab,Overall survival (OS)
Description
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.
Time Frame
Randomization to Death from Any Cause, up to 60 months
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
Randomization to Radiological Disease Progression or Death from Any Cause (Up to 24 Months)
Title
Objective Response Rate [ORR] (Percentage of Participants With Complete Response [CR] or Partial Response [PR])
Description
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.
Time Frame
Randomization to Disease Progression (Up To 24 Months)
Title
Disease Control Rate [DCR] (Percentage of Participants With Complete Response [CR], Partial Response [PR] or Stable Disease [SD])
Description
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.
Time Frame
Randomization to Disease Progression (Up To 24 Months)
Title
Duration of Response (DoR)
Description
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.
Time Frame
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)
Title
Number of participants experiencing an adverse event (AE)
Description
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.
Time Frame
Randomization to end of study (up to 24 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of Sintilimab Plus Ramucirumab as First-line Treatment for G/EGJ Adenocarcinoma (ORIENT-106)
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