Radiotherapy Combined With Tislelizumab and Irinotecan in MSS/pMMR Recurrence and Metastatic Colorectal Cancer

NCT05160727 | Unknown Phase 2

• 1 other identifier: CARTOnG-2104
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Explore the efficacy of radiotherapy combined with Tislelizumab and irinotecan in MSS/pMMR inoperable recurrent and metastatic colorectal cancer patients; To evaluate the safety and tolerability of radiotherapy combined with Tislelizumab and irinotecan in MSS/pMMR inoperable recurrent and metastatic colorectal cancer; To evaluate the radiosensitization effects of Tslelizumab and irinotecan;

Conditions

Mismatch Repair-proficient; Colorectal Cancer Metastatic; Microsatellite Stable

Keywords

Tislelizumab; Irinotecan; colorectal cancer; mismatch repair-proficient; microsatellite stable

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  in radiation field

  18 weeks after treatment completion

Study Arms (1)

Treatment group

EXPERIMENTAL

Concurrent Chemoradiotherapy: Radiation: The dose is determined according to the treatment site and the purpose of treatment. Irinotecan: 80mg/m2/w (UGT1A1\*28 and \*6: 6/6+GG) or 65mg/m2/w (UGT1A1\*28 and \*6: 6/7+GG or 6/6+GA) or 50mg/m2/w (UGT1A1\*28 and \*6: 7/7+GG or 6/6+AA or 6/7+GA) Tislelizumab: 200mg ivgtt d1 q3w Consolidation therapy: 2 weeks after the completion of chemoradiotherapy. Irinotecan: 200mg/m2 ivgtt d1 q3w. Tislelizumab: 200mg ivgtt d1 q3w. Efficacy assessment every 3 cycles.

Drug: Tislelizumab; Drug: Irinotecan; Radiation: radiotherapy

Interventions

Tislelizumab DRUG

200mg ivgtt d1 q3w

Treatment group

Irinotecan DRUG

Concurrent Chemoradiotherapy: Irinotecan: 80mg/m2/w (UGT1A1\*28 and \*6: 6/6+GG) or 65mg/m2/w (UGT1A1\*28 and \*6: 6/7+GG or 6/6+GA) or 50mg/m2/w (UGT1A1\*28 and \*6: 7/7+GG or 6/6+AA or 6/7+GA) Consolidation therapy: 2 weeks after the completion of chemoradiotherapy. Irinotecan: 200mg/m2 ivgtt d1 q3w.

Treatment group

radiotherapy RADIATION

radiotherapy

Treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary signing of informed consent;
• Aged 18-70 years old, regardless of gender;
• Histologically confirmed as inoperable recurrent or metastatic colorectal adenocarcinoma;
• Previously received oxaliplatin and fluorouracil based chemotherapy; No previous treatment with irinotecan;
• NGS sequencing or immunohistochemistry prompts MSS/pMMR
• At least one measurable lesion;
• Palliative radiotherapy is required for clinical evaluation (except radiotherapy for bone or brain metastasis);
• ECOG scores 0-2;
• Expected survival ≥ 6 months;
• The organ function of the patient was normal within 7 days before treatment, and the function of important organs met certain requirements.

You may not qualify if:

• Pregnant or breastfeeding women;
• There were primary lesions or metastases in the radiation field and had received radiotherapy before;
• Previously received PD-1, PD-L1 or PD-L2 for any indication;
• Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ;
• If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance;
• Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months;
• Organ transplantation requires immunosuppressive therapy Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases;
• Subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC)≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP).

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

tislelizumab; Irinotecan; Radiotherapy

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

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Therapeutics

Study Officials

• Ji Zhu, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji Zhu, MD

CONTACT

0571-88128142; leo.zhu@126.com

Ning Zhou, MD

CONTACT

0571-88128142; zhouning@zjcc.org.cn

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: Professor

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 16, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)