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

NCT04202601 | Unknown Phase 1

• 1 other identifier: CIBI310Y101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  Approximately 40 months after the first participant is randomized

Secondary Outcomes (14)

• Arms 1: Neoadjuvant therapy group

  Approximately 40 months after the first participant is randomized

• Arms 1: Neoadjuvant therapy group

  Approximately 40 months after the first participant is randomized

• Arms 1: Neoadjuvant therapy group

  Approximately 40 months after the first participant is randomized

• Arms 1: Neoadjuvant therapy group

  Approximately 40 months after the first participant is randomized

• Arms 1: Neoadjuvant therapy group

  Approximately 40 months after the first participant is randomized

Study Arms (3)

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

Interventions

Sintilimab DRUG

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.

Neoadjuvant therapy group; first-line therapy group; ≥second-line therapy group

IBI310 DRUG

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.

Neoadjuvant therapy group; first-line therapy group; ≥second-line therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University: lead
• Innovent Biologics (Suzhou) Co. Ltd.: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Lin Shen, professor

CONTACT

86-10-88196561; linshenpku@163.com

Zhi Peng, Associate Professor

CONTACT

86-10-88196561; zhipeng3@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,Professor,Chief of Department of GI Oncology,Peking University Cancer Hospital

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 17, 2019
• Study Start: December 13, 2019
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 19, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)