NCT04202601

Efficacy and Safety Evaluation of Sintilimab in Combination With IBI310 as Treatment in Patients With EBV-Positive Gastric Cancer

Efficacy and Safety Evaluation of Sintilimab in Combination With IBI310 as Treatment in Patients With Gastric Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2019-12-13
• Primary completion: 2022-09-01
• Completion: 2022-12-01
• First posted: 2019-12-17
• Last updated: 2019-12-19

Locations

1 site across 1 country: China