Sintilimab (IBI308) Combined With Bevacizumab + XELOX Regimen in Metastatic Colorectal Cancer

NCT04194359 | Unknown Phase 2 DMC

• 1 other identifier: 2020-552
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

A phase II clinical study of Sintilimab (IBI308) combined with Bevacizumab, Oxaliplatin and Capecitabine regimen as first-line treatment in patients with RAS-mutant and microsatellite stable metastatic colorectal cancer. A total of 25 patients are planned to be enrolled.

Conditions

Metastatic Colorectal Cancer; RAS Mutation; Microsatellite Stable

Keywords

RAS-mutant Metastatic Colorectal Cancer; Immunotherapy; Anti-PD-1; Checkpoint; Efficacy; Safety; Microsatellite stable

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate

  Objective Response Rate was defined as the proportion of patients with a best objective response of complete response (CR) or partial response (PR) according to RECIST criteria (version 1.1).

  From Baseline to disease progress, up to 18 months

• Adverse Events and Serious Adverse Events

  Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0.

  From Baseline to primary completion date, about 2 years

Secondary Outcomes (2)

• Disease Control Rate

  From Baseline to disease progress, up to 18 months

• Progression free survival

  From Baseline to primary completion date, about 2 years

Study Arms (1)

Sintilimab (IBI308) plus Bevacizumab, Oxaliplatin and Capecitabine

EXPERIMENTAL

Sintilimab (IBI308)：200MG, once every three weeks; Bevacizumab:7.5mg/kg, once every three weeks; oxplatin: 135 mg per square meter body surface, once every three weeks; Capecitabine : Capecitabine 1 gram per square meter body surface area, from the first day to the 14th day

Drug: Sintilimab (IBI308)+bevacizumab+oxaliplatin+capecitabine

Interventions

Sintilimab (IBI308)+bevacizumab+oxaliplatin+capecitabine DRUG

Humanized PD-1 antibody (Sintilimab, IBI308)+bevacizumab+oxaliplatin+capecitabine

Sintilimab (IBI308) plus Bevacizumab, Oxaliplatin and Capecitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age ≥ 18 years old, ≤ 75 years old;
• Metastatic colorectal adenocarcinoma confirmed by histology and unresectable metastatic colorectal cancer confirmed by a multidisciplinary team;
• RAS gene mutation, BRAF wild-type and microsatellite stable confirmed by polymerase chain reaction using a panel of six mononucleotide repeat markers (BAT-25, BAT-26, NR-21, NR-24, NR-27, and MONO-27);
• ECOG performance status of 0-1;
• Life expectancy≥3 months;
• Adequate organ and bone marrow functions: absolute neutrophil count \>1.5×109/L, hemoglobin \>8 g/dL, platelet count \>100×109/L, prothrombin time \<1.5 upper limit of normal (ULN), activated partial thromboplastin time \<1.5 ULN, bilirubin ≤1.5×ULN (could be extended to 3×ULN in case of liver metastasis), blood aspartate aminotransferase and alanine aminotransferase ≤2.5×ULN (could be extended to 5×ULN in case of liver metastasis), serum creatinine level ≤1.5×ULN or creatinine clearance ≥50 mL/min, urinary protein / creatinine ratio \< 1 (or urine analysis \< 1 + or 24-hour urinary protein \< 1g / 24 h;
• Informed consent has been signed;
• The presence of at least one measurable lesion assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;

You may not qualify if:

• received previous treatment with any anti-programmed cell death protein 1 (PD-1) or anti-PD-L1 antibody;
• received treatment with corticosteroids or other immunosuppressive agents within 14 days prior to study drug administration;
• presence of autoimmune disease, known interstitial lung disease;
• those with previous or concurrent malignancies expect for basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ that have undergone radical treatment.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the Second Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• Fang X, Zhu N, Zhong C, Wang L, Li J, Weng S, Hu H, Dong C, Li D, Song Y, Xu D, Wang J, Sun L, Wang J, Wang Z, Cao H, Liao X, Yu N, Xiao Q, Mi M, Zhang S, Ding K, Yuan Y. Sintilimab plus bevacizumab, oxaliplatin and capecitabine as first-line therapy in RAS-mutant, microsatellite stable, unresectable metastatic colorectal cancer: an open-label, single-arm, phase II trial. EClinicalMedicine. 2023 Jul 27;62:102123. doi: 10.1016/j.eclinm.2023.102123. eCollection 2023 Aug.

  PMID: 37554125 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ying Yuan, MD

  The Second Affiliated Hospital of Medical College of Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: February 4, 2021
• Primary Completion: November 30, 2022
• Study Completion: December 12, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

CN (1)