Efficacy and Safety Evaluation of Sintilimab in Combination With IBI310 as Treatment in Patients With EBV-Positive Gastric Cancer
NCT ID: NCT04202601
Last Updated: 2019-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
80 participants
INTERVENTIONAL
2019-12-13
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Neoadjuvant therapy group
Sintilimab
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.
IBI310
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.
first-line therapy group
Sintilimab
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.
IBI310
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.
≥second-line therapy group
Sintilimab
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.
IBI310
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.
Interventions
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Sintilimab
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.
IBI310
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Peking University
OTHER
Responsible Party
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Shen Lin
MD,Professor,Chief of Department of GI Oncology,Peking University Cancer Hospital
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Shen Lin, Professor
Role: primary
Other Identifiers
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CIBI310Y101
Identifier Type: -
Identifier Source: org_study_id