XELOX +Bev +Tislelizumab for First-line Treatment of MSS/pMMR RAS-mutated mCRC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

The goal of this clinical trial is to compare XELOX +Bev +Tislelizumab with standard chemotherapy,in MSS/pMMR-type RAS-mutated metastatic colorectal adenocarcinoma. The main questions it aims to answer are efficacy and safety of the regimen of XELOX +Bev +Tislelizumab. The investigators want to transform ras-mutated colorectal cancer into a "hot tumor" through the combination of anti-vascular therapy and chemotherapy, and then achieve better therapeutic effect through the combination with immunotherapy. Participants will receive the regimen of XELOX +Bev +Tislelizumab.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed initially unresectable MSS/pMMR-type RAS-mutant metastatic colorectal adenocarcinoma;

ECOG score of 0 or 1;

Ability to swallow oral medications;

Have at least one measurable lesion (according to RECIST v1.1 standard);

Disqualifiers

Previously received bevacizumab or anti-CTLA4, anti-PD-1/PD-L1 therapeutic antibodies or pathway-targeted drugs;

Received radiotherapy within 4 weeks before the evaluation;

Symptomatic peripheral neuropathy > grade 2 (CTCAE5.0 standard);

Received live vaccine or systemic immune stimulant (including but not limited to interferon or interleukin 2) within 1 month;

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab+Bevacizumab+Oxaliplatin+Capecitabine

    Drug

    Use the above medications on a regular basis.

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: XELOX +Bev +TislelizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

ORR of regimen of XELOX +Bev +Tislelizumab

Time frame
2 years

Secondary outcomes

1

Duration of Response (DoR)

Time frame
2 years
2

Disease Control Rate (DCR);

Time frame
2 years
3

Median Progression-Free Survival (mPFS)

Time frame
2 years
4

12-month PFS rate

Time frame
12 months

Other outcomes

Sponsors and contacts

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