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

NCT ID: NCT05160727

Last Updated: 2021-12-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2024-10-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

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.

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

200mg ivgtt d1 q3w

Irinotecan

Intervention Type: 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.

radiotherapy

Intervention Type: RADIATION

radiotherapy

Interventions

Tislelizumab

200mg ivgtt d1 q3w

Intervention Type: DRUG

Irinotecan

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.

Intervention Type: DRUG

radiotherapy

radiotherapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Voluntary signing of informed consent;

2. Aged 18-70 years old, regardless of gender;

3. Histologically confirmed as inoperable recurrent or metastatic colorectal adenocarcinoma;

4. Previously received oxaliplatin and fluorouracil based chemotherapy; No previous treatment with irinotecan;

5. NGS sequencing or immunohistochemistry prompts MSS/pMMR

6. At least one measurable lesion;

7. Palliative radiotherapy is required for clinical evaluation (except radiotherapy for bone or brain metastasis);

8. ECOG scores 0-2;

9. Expected survival ≥ 6 months;

10. The organ function of the patient was normal within 7 days before treatment, and the function of important organs met certain requirements.

Exclusion Criteria

1. Pregnant or breastfeeding women;

2. There were primary lesions or metastases in the radiation field and had received radiotherapy before;

3. Previously received PD-1, PD-L1 or PD-L2 for any indication;

4. Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ;

5. 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;

6. 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;

7. Organ transplantation requires immunosuppressive therapy Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases;

8. 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ji Zhu, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ji Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ji Zhu, MD

Role: CONTACT

leo.zhu@126.com

0571-88128142 ext. +86

Ning Zhou, MD

Role: CONTACT

zhouning@zjcc.org.cn

0571-88128142 ext. +86

Facility Contacts

Ji zhu, MD

Role: primary

leo.zhu@126.com

0571-88128142 ext. +86

Ning Zhou, MD

Role: backup

zhouning@zjcc.org.cn

0571-88128142 ext. +86

Other Identifiers

CARTOnG-2104

Identifier Type: -

Identifier Source: org_study_id