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pMMRPhase 2NCT05731726

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

A Phase 2 study testing Serplulimab, Capecitabine and Oxaliplatin in people with pMMR and MSS, run by Zhejiang University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
pMMR, MSS, MSI-L
What is being tested?
Serplulimab, Capecitabine and Oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
22 Feb 2023to 30 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • The lower margin of the tumor is less than 10cm from the anus verge.
  • cT2N1-2M0, cT3N0-2M0, cT4N0-2M0 MSS with MRF(-) assessed by MRI.
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  • Primary tumor can be detected by CT or MRI.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Eligible tumor tissues were identified for MSI/MMR assays.
  • Hepatitis B Surface Antigen (HBsAg) (-).
  • If HBsAg (+) , HBV-DNA must be less than 2500 copies/mL or 500 IU/mL to be enrolled.
  • Patients with HCV antibody (-) or HCV-RNA negative can be enrolled. Aspartate aminotransferase (AST) must be ≤ 3 x ULN for the lab. If HCV-RNA is positive, patients with both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) performed ≤3×ULN could be enrolled. Patients infected with both hepatitis B virus and hepatitis C virus should be excluded (positive for HBsAg or HBcAb and positive for HCV antibodies).

Who cannot join

  • 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.
  • History of myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms in women) in the 6 months prior to enrollment (QTc interval calculated by Fridericia formula).
  • According to New York College of Cardiology (NYHA) standards for Grade III-IV cardiac insufficiency or cardiac color ultrasound: left ventricular ejection fraction (LVEF) <50%.Poor hypertension control (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg), a past hypertensive crisis or hypertensive encephalopathy.
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  • Poor hypertension control (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg), a past hypertensive crisis or hypertensive encephalopathy.
  • Patients had undergone major surgery within 28 days prior to enrollment. Patients with tumor biopsy or lymph node dissection biopsy were admitted. Patients undergoing enterostomy due to intestinal obstruction were admitted.
  • The patients had previously been treated with other antibodies/drugs that target immune checkpoints, such as PD-1, PD-L1, and cytotoxic T lymphocyte-associated Antigen 4 (CTLA-4).
  • Patients are participating in other clinical studies, or plan to start this study treatment less than 14 days from the end of the previous clinical study.
  • Uncontrolled tumor-related pain.
  • A known history of severe allergy to any monoclonal antibody.
  • Known to be allergic or intolerance to any oxaliplatin and capecitabine ingredients.
  • Pregnant or lactating women.
  • The investigators determined that the patient had other factors that might have led to the early termination of the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kefeng Ding, doctor contact

+86 13588425440

dingkefeng@zju.edu.cn

China1 site, 1 recruiting

  • Second Affiliated Hospital School of Medicine Zhejiang University

    Hangzhou, Zhejiang, 310000

    Jinjie He, Doctor, +86 13588425440, hjj18279@163.com

    Kefeng Ding, Doctor

    Recruiting

Other trials in China

About this study

Official title: A Phase II Study to Explore the Neoadjuvant Treatment of Serplulimab Combined With CAPEOX + Celecoxib in the Treatment of Locally Advanced Rectal Cancer

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.

Being tested
Serplulimab, Capecitabine, Oxaliplatin, Celecoxib
Keywords
Rectal cancer, Serplulimab, Celecoxib, CAPEOX, neoadjuvant therapy
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SerplulimabDrug

    Also called HLX10

    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.

  • CapecitabineDrug

    Also called Xeloda

    Given PO

  • OxaliplatinDrug

    Also called OHP

    Given IV

  • CelecoxibDrug

    Also called Given PO

    celebrex

Study groups in NCT05731726
Study groupRoleWhat they receive
Serplulimab+CAPEOX+celecoxibExperimentalParticipants will receive serplulimab 300 mg every 3 weeks (Q3W) concurrently with CAPEOX regimen: Oxaliplatin(130mg/m2) on day 1 of each cycle and Capecitabine, 1000mg/m2, PO, BID, day1-14, q3w and celecoxib, 200mg, PO, BID, day1-21, q3w. Treatment repeats every 3 weeks for 4-8 cycles followed by surgery (total mesorectal excision, TME).
Receives: Drug: Serplulimab; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Celecoxib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response rates

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

    Measured: 1 year

Secondary outcomes (7)

  1. Major pathological response rates

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

    Measured: 1 year

  2. Rate of clinical complete response rate (cCR)

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

    Measured: 1 year

  3. R0 resection rates

    The proportion of patients achieved a complete resection with negative margin

    Measured: 1 year

  4. Treatment-related adverse events.

    Assessed by evaluation of treatment-related adverse events.

    Measured: 1 year

  5. Detection of MRD

    To detect ctDNA in peripheral blood before and after treatment

    Measured: 1year

  6. single cell sequence

    Use single cell sequence to describe changes in the microenvironment of rectal cancer before and after treatment

    Measured: 1year

  7. Disease Free Survival

    Defined as the interval from enrollment to locoregional or metastatic recurrence or the appearance or a secondary colorectal cancer or death, whichever occurs first

    Measured: 3years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2023
  2. Study start22 Feb 2023
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05731726
Sponsor's protocol ID
ASTRUM-REC01
Status last verified
Mar 2026
First submitted
7 Feb 2023
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Serplulimab, Capecitabine and Oxaliplatin in people with pMMR and MSS, run by Zhejiang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kefeng Ding, doctor (+86 13588425440, dingkefeng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rates (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05731726.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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