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Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer

ConditionspMMRMSSMSI-LLocally Advanced Rectal Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University

About this trial

Colorectal cancer of Mismatch Repair-proficient (pMMR)/ Microsatellite Stability (MSS) accounts for approximately 85% of all colorectal cancer patients, which might be insensitive to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy, such as CAPEOX regimen, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Celecoxib, a COX-2 inhibitor, can improve the immune microenvironment and have a potential to synergy with immunotherapy. Chemotherapy can improve the immunogenicity of cancer cells that might enhance the efficacy of immunotherapy. The aim of this study is to explore whether chemotherapy and cyclooxygenase (COX) inhibitors combined with anti-PD-1 monoclonal antibody (mAb) could improve efficacy for resectable colorectal cancer patient with the pMMR/MSS phenotype.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing and able to provide written informed consent.

Male or female subjects ≧ 18 years ≦ 75 of age.

Histological or cytological documentation of adenocarcinoma of the rectum.

No previous any systemic anticancer therapy for rectal cancer disease.

Disqualifiers

Patients with recurrent rectal cancer or a history of pelvic radiotherapy.

Patients with a history of inflammatory bowel disease.

Patients with acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease (HIV1 antibody, HIV2 antibody, HTLV1 antibody positive) should be excluded.

Patients who are preparing for or have previously received an organ or bone marrow transplant.

Trial design

Design model

Single group

Treatments tested in this trial

  • Serplulimab

    Drug

    Serplulimab is an innovative monoclonal antibody targeting PD-1, developed by Shanghai Henlius Biotech, Inc. 300 mg, q3w. For the timing of serplulimab, there is a subgroup developed, all enrolled patients will be divided into 2 subgroups in 1:1 ratio, the fasting group and the control group. For the fasting group patients, fasting starts from 8 p.m. the day before treatment and concludes at 12 p.m. on the treatment day, water is allowed. For the control group patients, they have meals according to their habits.

  • Capecitabine

    Drug

    Given PO

  • Oxaliplatin

    Drug

    Given IV

  • Celecoxib

    Drug

    celebrex

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Serplulimab+CAPEOX+celecoxibExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response rates

Proportion of patients experiencing a pCR to perioperative PD-1 antibody

Time frame
1 year

Secondary outcomes

1

Major pathological response rates

The proportion of patients experiencing a major pathological response to perioperative PD-1 antibody

Time frame
1 year
2

Rate of clinical complete response rate (cCR)

Proportion of patients experiencing a cCR to perioperative PD-1 antibody

Time frame
1 year
3

R0 resection rates

The proportion of patients achieved a complete resection with negative margin

Time frame
1 year
4

Treatment-related adverse events.

Assessed by evaluation of treatment-related adverse events.

Time frame
1 year

Other outcomes

Sponsors and contacts

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

Zhejiang University

Lead sponsor

Source ClinicalTrials.gov
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