Gastric AdenocarcinomaPhase 3NCT04675983
A Study of Sintilimab Plus Ramucirumab as First-line Treatment for G/EGJ Adenocarcinoma (ORIENT-106)
A Phase 3 study testing Sintilimab, Ramucirumab and Cisplatin in people with Gastric Adenocarcinoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- Sintilimab, Ramucirumab and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2021to 12 Feb 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Gastric Adenocarcinoma
- Being tested
- Sintilimab, Ramucirumab, Cisplatin, 5-fluorouracil, Oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Also called Tyvyt, IBI308
Administered IV
RamucirumabDrug
Also called LY3009806, IMC-1121B, Cyramza
Administered IV
CisplatinDrug
Administered IV
5-fluorouracilDrug
Administered IV
OxaliplatinDrug
Administered IV
CapecitabineDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Drug: Cisplatin; Drug: 5-fluorouracil; Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Randomization to Death from Any Cause, up to 60 months
Secondary outcomes (5)
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.
Measured: 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])
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.
Measured: 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])
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.
Measured: Randomization to Disease Progression (Up To 24 Months)
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.
Measured: 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)
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.
Measured: Randomization to end of study (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start10 Mar 2021
- Primary completion12 Feb 2023
- Study completion12 Feb 2023
Why it stopped: Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675983
- Sponsor's protocol ID
- CIBI308E302
- Status last verified
- Feb 2023
- First submitted
- 3 Dec 2020
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04675983
- Acronym / sponsor ID
- CIBI308E302
- Conditions
- Gastric Adenocarcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 12 Feb 2023 (actual)
- Study completion
- 12 Feb 2023 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sintilimab + Ramucirumab | Experimental | Drug: Sintilimab, Drug: RamucirumabRamucirumab 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+ 5-fluorouracil/Oxaliplatin+capecitabine | Active comparator | Drug: Cisplatin, Drug: 5-fluorouracil, Drug: Oxaliplatin, Drug: CapecitabineCisplatin 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SintilimabAlso: Tyvyt, IBI308Administered IV | Drug | Sintilimab + Ramucirumab |
| RamucirumabAlso: LY3009806, IMC-1121B, CyramzaAdministered IV | Drug | Sintilimab + Ramucirumab |
| CisplatinAdministered IV | Drug | Cisplatin+ 5-fluorouracil/Oxaliplatin+capecitabine |
| 5-fluorouracilAdministered IV | Drug | Cisplatin+ 5-fluorouracil/Oxaliplatin+capecitabine |
| OxaliplatinAdministered IV | Drug | Cisplatin+ 5-fluorouracil/Oxaliplatin+capecitabine |
| CapecitabineAdministered orally | Drug | Cisplatin+ 5-fluorouracil/Oxaliplatin+capecitabine |
Primary outcome
Safety and tolerability of sintilimab plus ramucirumab,Overall survival (OS)
Time frame: Randomization to Death from Any Cause, up to 60 months
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.
5 secondary outcomes
Progression-free Survival (PFS)
Time frame: 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])
Time frame: 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])
Time frame: Randomization to Disease Progression (Up To 24 Months)
Duration of Response (DoR)
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)
Number of participants experiencing an adverse event (AE)
Time frame: Randomization to end of study (up to 24 months)
Results and safety
The study was stopped early (reason given: Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sintilimab, Ramucirumab and Cisplatin in people with Gastric Adenocarcinoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of sintilimab plus ramucirumab,Overall survival (OS) (time frame: Randomization to Death from Any Cause, up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.