Phase II Study of Tislelizumab Combined With Cetuximab and Irinotecan in the Treatment of Recurrent, Refractory mCRC

NCT05143099 | Unknown Phase 2

• 1 other identifier: TEC
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm, open phase II study to evaluate the efficacy and safety of tislelizumab combined with cetuximab + irinotecan in the treatment of Ras wild-type recurrent and refractory colorectal cancer. This study will include Ras wild-type colorectal cancer that failed at least second-line treatment in the past, including chemotherapy (oxaliplatin, irinotecan, fluorouracil) with or without targeted drugs (cetuximab, bevacizumab). 33 patients were planned to be treated with tislelizumab combined with cetuximab + irinotecan every 2 weeks. The enrollment time is expected to be 12 months and the follow-up is 24 months.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  proportion of patients with complete and partial remission in the best efficacy

  24 months after the last subject participating in

Secondary Outcomes (3)

• Disease control rate (DCR)

  24 months after the last subject participating in

• Progression free survival time (PFS）

  24 months after the last subject participating in

• Overall survival (OS）

  36 months after the last subject participating in

Other Outcomes (1)

• biomarker analysis

  12 months after the last subject participating in

Study Arms (1)

1

EXPERIMENTAL

tislelizumab combined with cetuximab and irinotecan

Drug: TEC

Interventions

TEC DRUG

tislelizumab（an anti-PD-1 monoclonal antibody）+cetuximab（monoclonal antibody against EGFR）+irinotecan

1

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years；
• The ECOG PS score of the eastern United States cancer cooperation group was 0 or 1;
• Ras wild-type colorectal cancer diagnosed by histology and / or cytology has metastasis or recurrence that cannot be cured by surgery;
• Have received at least second-line systemic anti-tumor treatment for MCRC and failed, in which chemotherapy drugs can include fluorouracil, oxaliplatin and irinotecan, such as XELOX, FOLFOX, FOLFIRI, folfoxiri and xeliri; targeted drugs can be combined or not, such as cetuximab and bevacizumab;
• At least one measurable lesion defined according to RECIST version 1.1;
• Patients with fertility must be willing to take efficient contraceptive measures during the study period and ≥ 120 days after the last administration of tirelizumab; female patients have negative urine or serum pregnancy test results ≤ 7 days before the first administration of the study drug;
• Fully understand this study and voluntarily sign the informed consent form.

You may not qualify if:

• Absolute neutrophil count (ANC) \< 1.5 × 109 / L, or platelet count \< 100 × 109 / L, or hemoglobin \< 9g / dL or 90g / L or 5.6mmol/l; Blood transfusion or growth factor support within 2 weeks before enrollment are not allowed to meet the enrollment criteria;
• Serum total bilirubin \> 1.5 times the upper limit of normal value (ULN); Patients with liver metastasis \> 2.5 times ULN;
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2.5 times ULN, or ALT and / or ast \> 5 times ULN in patients with liver metastasis;
• Serum creatinine \> 1.5 times the upper limit of normal value (ULN), or creatinine clearance \< 60ml / min (calculated according to Cockcroft Gault formula);
• Partial prothrombin time (APTT) or prothrombin time (PT) \> 1.5 times ULN (subject to the normal value of clinical trial and Research Center);
• Albumin \< 30g / L;
• Clinically significant electrolyte abnormalities;
• Any previous histological or hematological ctDNA test showed mismatch repair gene deletion (dmmr), microsatellite instability (MSI-H) and BRAF mutant patients;
• Previous immunotherapy, including anti-PD-1, anti-PD-L1, anti-CTLA-4 or any cellular immunotherapy;
• Have a history of active autoimmune disease or autoimmune disease that may recur;
• Patients with any disease requiring systemic treatment with corticosteroids (the dose of prednisone or equivalent drug \> 10 mg / day) or other immunosuppressive drugs within ≤ 14 days before the administration of the first study drug need not be excluded if they have used any of the following steroid treatment schemes at present or in the past:
• Adrenal replacement steroids (dose of prednisone or equivalent ≤ 10 mg / day);
• Local, ocular, intra-articular, intranasal or inhaled corticosteroids with very low systemic absorption;
• Short term (≤ 7 days) prophylactic use of corticosteroids (e.g. for the treatment of contrast medium allergy) or for the treatment of non autoimmune diseases (e.g. delayed type hypersensitivity caused by contact allergens);
• there are a history of interstitial lung disease, non infectious pneumonia, pulmonary fibrosis, acute lung disease, or poorly controlled systemic diseases (including but not limited to diabetes, hypertension, etc.).

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Tianshu Liu

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Oncology Department

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: February 1, 2021
• Primary Completion: December 12, 2022
• Study Completion: February 28, 2024
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)