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

Colorectal Cancer Metastatic Clinical Trial

Official title:

A Multicenter Phase II Clinical Study of Radiotherapy Combined With Tislelizumab and Irinotecan in MSS/pMMR Inoperable Recurrence and Metastatic Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05160727
• Other study ID #: CARTOnG-2104
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2021
• Est. completion date: October 2024

Study information

• Verified date: December 2021
• Source: Zhejiang Cancer Hospital
• Contact: Ji Zhu, MD
• Phone: 0571-88128142
• Email: leo.zhu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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;

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms
• Microsatellite Stable
• Recurrence

Intervention

Drug:
• Tislelizumab
200mg ivgtt d1 q3w
• 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.

Radiation:
• radiotherapy
radiotherapy

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	in radiation field	18 weeks after treatment completion