CClinicalTrials.gg
Status unknownNCT05160727Updated Dec 20, 2021

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

A Phase 2 interventional study of Tislelizumab and Irinotecan in Mismatch Repair-proficient, Colorectal Cancer Metastatic and Microsatellite Stable, sponsored by Zhejiang Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-12-20.

Sponsored by Zhejiang Cancer Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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;

02

Conditions studied

  • Mismatch Repair-proficient
  • Colorectal Cancer Metastatic
  • Microsatellite Stable

Keywords

  • Tislelizumab
  • Irinotecan
  • colorectal cancer
  • mismatch repair-proficient
  • microsatellite stable
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 44 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Zhejiang Cancer Hospital is the lead sponsor of 271 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: Tislelizumab · Drug: Irinotecan · Radiation: radiotherapy

Interventions

  • DrugTislelizumab

    200mg ivgtt d1 q3w

  • DrugIrinotecan

    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.

  • Radiationradiotherapy

    radiotherapy

06

What researchers measure

Primary outcomes

  1. Objective response rate

    in radiation field

    Time frame: 18 weeks after treatment completion

07

Study locations

1 of 1 sites recruiting
  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang 310000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05160727
Lead sponsor
Zhejiang Cancer Hospital
Responsible party
Ji Zhu, MD (Professor, Zhejiang Cancer Hospital) — Principal investigator
First posted
Dec 16, 2021
Start date
Oct 1, 2021
Primary completion
Oct 2024 (estimated)
Completion
Oct 2024 (estimated)
Last update
Dec 20, 2021

Study contacts

Ji Zhu, MD
Contact
leo.zhu@126.com
0571-88128142 ext. +86
Ning Zhou, MD
Contact
zhouning@zjcc.org.cn
0571-88128142 ext. +86
Ji Zhu, MD
principal investigator · Zhejiang Cancer Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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