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Neoadjuvant CAPOX Plus Tislelizumab vs CAPOX in MSS High-Risk Locally Advanced Colon Cancer

ConditionsColonic NeoplasmsNeoadjuvant TherapyImmune Checkpoint Inhibitors
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital of Guangxi Medical University

About this trial

Building on earlier exploratory work, this study further designs a multi-institutional, prospective, randomized clinical trial to evaluate the efficacy and safety of the combination therapy of the immune checkpoint inhibitor Tislelizumab with CAPOX for neoadjuvant treatment in high-risk locally advanced MSS-type colorectal cancer, as well as its impact on patient outcomes. This study aims to provide new evidence for the clinical practice of treating MSS-type colorectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years old and ≤75 years old.

Pathologically diagnosed MSS ((confirmed by microsatellite stable detection or next-generation target sequencing) or (confirmed by immunohistochemistry)) colon adenocarcinoma.

The lower edge of the tumor is more than 12cm from the anus as measured by colonoscopy and the lower edge of the tumor cannot be directly palpated during rectal examination.

Enhanced CT stage T4 or T1-4 N+ without multiple primary tumors or distant metastasis.

Disqualifiers

Enhanced CT stage (T1-3N0M0)

Multifocal colorectal cancer.

CT or MRI in the mid-sagittal plane shows that the lower border of the tumor is below the line connecting the sacrococcygeal promontory and the upper border of the pubic symphysis.

Tumor obstruction or high risk of obstruction, bleeding, and/or perforation requiring emergency surgery or stent placement.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tislelizumab

    Drug

    200 mg on Day 1 every 3 weeks and repeat for 2 or 4 cycles. The incidence of adverse events with Tislelizumab is relatively low. The Tislelizumab dose adjustment was implemented according to the prescribing information.

  • Oxaliplatin

    Drug

    Oxaliplatin 130mg/m2 on Day 1 every 3 weeks and repeat for 2 or 4 cycles. The dose reduction protocol for oxaliplatin-induced toxicity was implemented according to the study in British Journal of Cancer (2018) 118:1322-1328.

  • Capecitabine

    Drug

    Oral Capecitabine 1000 mg/m2 twice daily combined with oxaliplatin chemotherapy from Day 1 to Day 14 every 3 weeks and repeat for 2 or 4 cycles. The dose reduction protocol for capecitabine-induced toxicity was implemented according to the study in British Journal of Cancer (2018) 118:1322-1328.

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: CAPOX combined with TislelizumabExperimental treatment 3 interventions
Group B: CAPOX chemotherapyPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response (pCR)

the proportion of tumor regression grades 0 (TRG0, disappearance of tumor cells) in the pathological specimens of surgically resected tumors.

Time frame
3-5 days of postoperative pathological examination

Secondary outcomes

1

R0 resection

the rate of a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.

Time frame
3-5 days of postoperative pathological examination
2

Disease-free survival (DFS)

3-year disease-free survival

Time frame
From date of the patient signs the informed consent form until the date of earliest occurrence of the patient's tumor recurrence or death, whichever came first, assessed up to 36 months.
3

Overall survival (OS)

3-year overall survival

Time frame
From the date of the patient signs the informed consent form until the date of the patient's death, assessed up to 36 months.
4

Adverse events (AEs)

the rate of adverse events

Time frame
up to half a year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Guangxi Medical University

Lead sponsor

The First Affiliated Hospital of Xiamen University

Collaborator

The First Affiliated Hospital of University of South China

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: