Advanced Gastric or Gastroesophageal Junction (GEJ) AdenocarcinomaPhase 1/2NCT04202601
Efficacy and Safety Evaluation of Sintilimab in Combination With IBI310 as Treatment in Patients With EBV-Positive Gastric Cancer
A Phase 1/2 study testing Sintilimab and IBI310 in people with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma, run by Peking University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of sintilimab+ IBI310 for EBV-Positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
- What is being tested?
- Sintilimab and IBI310
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2019to 1 Dec 2022
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ malignant tumor (including squamous carcinoma, adenocarcinoma, Signet-ring cell carcinoma).
- Confirmed EBV positive determined by in situ hybridization (ISH), analyzed with tumor tissue sample, either from a previous surgery or biopsy , within last 6 months
- Male or Female at least 18 years of age
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Has adequate organ function.
- Expected survival>=12 weeks
Show all 11Show fewer
- Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at the timing of enrollment.
- Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 6 months after the last dose of study medication.
- Applied to Arms 1: Has histologically confirmed gastric/GEJ malignant tumor, and were regarded as having clinical stage T3-T4aN0M0 or T2～4aN+M0
- Applied to Arms 2: Had no prior systemic treatment for metastatic disease.
- Applied to Arms 3: Received ≥1 prior systemic treatment for metastatic disease.
Who cannot join
- Has received prior therapy with an anti-programmed death (PD)-1, antiPD-L1, anti-PD L2, anti-CTLA-4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- Is currently participating in and receiving study therapy ,except those in the survival follow up period of an investigational agent study or non-interventional study .
- Received systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 4 weeks of first dose. Inhaled or topical steroids ,adrenal replacement steroid doses and steroid of prevention allergic reaction of i.v. contrast agent are permitted in the absence of active autoimmune disease.
- Received a live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.
- Has had major surgery (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to first dose of study medication, or anticipation of the need for major surgery during the course of study treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Shen Lin, Professor, 010-88196561, Linshenpku@163.com
Shen Lin, professor
About this study
Official title: Efficacy and Safety Evaluation of Sintilimab in Combination With IBI310 as Treatment in Patients With Gastric Cancer
The purpose of this study is to evaluate the efficacy and safety of sintilimab+ IBI310 for EBV-Positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
- Being tested
- Sintilimab, IBI310
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Arms 1: Neoadjuvant therapy group 20 patients Drug: Sintilimab Weight<60Kg: 3mg/kg Q3W Weight>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention：Perioperative Sintilimab+IBI310 are administered for 1-3 (6-18 weeks) cycles followed by 4 postoperative cycles (12 weeks) with Sintilimab monotherapy .
Arms 2: first-line therapy group, 30 patients Drug: Sintilimab Weight<60Kg: 3mg/kg Q3W Weight>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years.
Arms 3: ≥second-line therapy group, 30 patients Drug: Sintilimab Weight<60Kg: 3mg/kg Q3W Weight>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years.
IBI310Drug
Arms 1: Neoadjuvant therapy group, 20 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention：Perioperative Sintilimab+ IBI310 are administered for 1-3 (6-18 weeks) cycles followed by 4 postoperative cycles (12 weeks) with Sintilimab monotherapy .
Arms 2: first-line therapy group, 30 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years.
Arms 3: ≥second-line therapy group, 30 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant therapy group | Experimental | Not described Receives: Drug: Sintilimab; Drug: IBI310 |
| first-line therapy group | Experimental | Not described Receives: Drug: Sintilimab; Drug: IBI310 |
| ≥second-line therapy group | Experimental | Not described Receives: Drug: Sintilimab; Drug: IBI310 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arms 1: Neoadjuvant therapy group
Pathological complete regression (pCR):
Pathological complete regression (pCR) is defined as the proportion of patients with pathological complete regression (TRG1a) over the total number of patients evaluated centrally by the study pathologist
Measured: Approximately 40 months after the first participant is randomized
Arms 2: first-line therapy group
Objective response rate(ORR):
Objective response rate(ORR) of Sintilimab in combination with IBI310 in all participants in this group.
Measured: Approximately 40 months after the first participant is randomized
Arms 3:≥second-line therapy group
Objective response rate(ORR):
Objective response rate(ORR) of Sintilimab in combination with IBI310 in all participants in this group.
Measured: Approximately 40 months after the first participant is randomized
Secondary outcomes (14)
Arms 1: Neoadjuvant therapy group
R0 resection rate
Measured: Approximately 40 months after the first participant is randomized
Arms 1: Neoadjuvant therapy group
Event free survival(EFS)
Measured: Approximately 40 months after the first participant is randomized
Arms 1: Neoadjuvant therapy group
Objective response rate(ORR)
Measured: Approximately 40 months after the first participant is randomized
Arms 1: Neoadjuvant therapy group
Disease control rate(DCR)
Measured: Approximately 40 months after the first participant is randomized
Arms 1: Neoadjuvant therapy group
Overall survival(OS)
Measured: Approximately 40 months after the first participant is randomized
Arms 1: Neoadjuvant therapy group
Number of participants experiencing clinical and laboratory adverse events (AEs).
Measured: Approximately 40 months after the first participant is randomized
Arms 2: first-line therapy group
Progression-free survival (PFS）
Measured: Approximately 40 months after the first participant is randomized
Arms 2: first-line therapy group
Disease control rate (DCR）
Measured: Approximately 40 months after the first participant is randomized
Arms 2: first-line therapy group
Overall survival (OS）
Measured: Approximately 40 months after the first participant is randomized
Arms 2: first-line therapy group
( Number of participants experiencing clinical and laboratory adverse events (AEs).
Measured: Approximately 40 months after the first participant is randomized
Arms 3:≥second-line therapy group
Progression-free survival (PFS）
Measured: Approximately 40 months after the first participant is randomized
Arms 3:≥second-line therapy group
Disease control rate (DCR)
Measured: Approximately 40 months after the first participant is randomized
Arms 3:≥second-line therapy group
Overall survival (OS）
Measured: Approximately 40 months after the first participant is randomized
Arms 3:≥second-line therapy group
Number of participants experiencing clinical and laboratory adverse events (AEs)
Measured: Approximately 40 months after the first participant is randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start13 Dec 2019 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric or Gastroesophageal Junction (GEJ) AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Responsible party
- Principal investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202601
- Sponsor's protocol ID
- CIBI310Y101
- Status last verified
- Dec 2019
- First submitted
- 12 Dec 2019
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Sintilimab in Combination With IBI310 as Treatment in Patients With Gastric Cancer
- ClinicalTrials.gov ID
- NCT04202601
- Acronym / sponsor ID
- CIBI310Y101
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Study start
- 13 Dec 2019 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 17 Dec 2019 (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 purpose of this study is to evaluate the efficacy and safety of sintilimab+ IBI310 for EBV-Positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant therapy group | Experimental | Drug: Sintilimab, Drug: IBI310 |
| first-line therapy group | Experimental | Drug: Sintilimab, Drug: IBI310 |
| ≥second-line therapy group | Experimental | Drug: Sintilimab, Drug: IBI310 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ malignant tumor (including squamous carcinoma, adenocarcinoma, Signet-ring cell carcinoma).
- Confirmed EBV positive determined by in situ hybridization (ISH), analyzed with tumor tissue sample, either from a previous surgery or biopsy , within last 6 months
- Male or Female at least 18 years of age
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Has adequate organ function.
Key exclusion criteria (5 listed)
- Has received prior therapy with an anti-programmed death (PD)-1, antiPD-L1, anti-PD L2, anti-CTLA-4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- Is currently participating in and receiving study therapy ,except those in the survival follow up period of an investigational agent study or non-interventional study .
- Received systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 4 weeks of first dose. Inhaled or topical steroids ,adrenal replacement steroid doses and steroid of prevention allergic reaction of i.v. contrast agent are permitted in the absence of active autoimmune disease.
- Received a live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.
- Has had major surgery (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to first dose of study medication, or anticipation of the need for major surgery during the course of study treatment
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 |
|---|---|---|
| SintilimabArms 1: Neoadjuvant therapy group 20 patients Drug: Sintilimab Weight<60Kg: 3mg/kg Q3W Weight>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention：Perioperative Sintilimab+IBI310 are administered for 1-3 (6-18 weeks) cycles followed by 4 postoperative cycles (12 weeks) with Sintilimab monotherapy . Arms 2: first-line therapy group, 30 patients Drug: Sintilimab Weight<60Kg: 3mg/kg Q3W Weight>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years. Arms 3: ≥second-line therapy group, 30 patients Drug: Sintilimab Weight<60Kg: 3mg/kg Q3W Weight>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years. | Drug | Neoadjuvant therapy group, first-line therapy group, ≥second-line therapy group |
| IBI310Arms 1: Neoadjuvant therapy group, 20 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention：Perioperative Sintilimab+ IBI310 are administered for 1-3 (6-18 weeks) cycles followed by 4 postoperative cycles (12 weeks) with Sintilimab monotherapy . Arms 2: first-line therapy group, 30 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years. Arms 3: ≥second-line therapy group, 30 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years. | Drug | Neoadjuvant therapy group, first-line therapy group, ≥second-line therapy group |
Primary outcome
Arms 1: Neoadjuvant therapy group
Time frame: Approximately 40 months after the first participant is randomized
Pathological complete regression (pCR): Pathological complete regression (pCR) is defined as the proportion of patients with pathological complete regression (TRG1a) over the total number of patients evaluated centrally by the study pathologist
Arms 2: first-line therapy group
Time frame: Approximately 40 months after the first participant is randomized
Objective response rate(ORR): Objective response rate(ORR) of Sintilimab in combination with IBI310 in all participants in this group.
Arms 3:≥second-line therapy group
Time frame: Approximately 40 months after the first participant is randomized
Objective response rate(ORR): Objective response rate(ORR) of Sintilimab in combination with IBI310 in all participants in this group.
14 secondary outcomes
Arms 1: Neoadjuvant therapy group
Time frame: Approximately 40 months after the first participant is randomized
Arms 1: Neoadjuvant therapy group
Time frame: Approximately 40 months after the first participant is randomized
Arms 1: Neoadjuvant therapy group
Time frame: Approximately 40 months after the first participant is randomized
Arms 1: Neoadjuvant therapy group
Time frame: Approximately 40 months after the first participant is randomized
Arms 1: Neoadjuvant therapy group
Time frame: Approximately 40 months after the first participant is randomized
Arms 1: Neoadjuvant therapy group
Time frame: Approximately 40 months after the first participant is randomized
Arms 2: first-line therapy group
Time frame: Approximately 40 months after the first participant is randomized
Arms 2: first-line therapy group
Time frame: Approximately 40 months after the first participant is randomized
Arms 2: first-line therapy group
Time frame: Approximately 40 months after the first participant is randomized
Arms 2: first-line therapy group
Time frame: Approximately 40 months after the first participant is randomized
Arms 3:≥second-line therapy group
Time frame: Approximately 40 months after the first participant is randomized
Arms 3:≥second-line therapy group
Time frame: Approximately 40 months after the first participant is randomized
Arms 3:≥second-line therapy group
Time frame: Approximately 40 months after the first participant is randomized
Arms 3:≥second-line therapy group
Time frame: Approximately 40 months after the first participant is randomized
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sintilimab and IBI310 in people with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma, run by Peking University 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 11 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: status not confirmed, as of the sponsor's last update on 19 Dec 2019. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Shen, professor (86-10-88196561, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arms 1: Neoadjuvant therapy group (time frame: Approximately 40 months after the first participant is randomized). The study lists 3 primary outcomes in all. 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 19 Dec 2019; AzTrials last refreshed its copy on 7 Nov 2026.