Short-course radiotherapy plus CAPOX chemotherapy with serplulimab and bevacizumab for mid-low MSS rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, phase II prospective trial of total neoadjuvant therapy for mid-low locally advanced MSS/pMMR rectal adenocarcinoma. Participants receive short-course radiotherapy followed by sequential CAPOX chemotherapy combined with the PD-1 antibody serplulimab and the anti-VEGF agent bevacizumab prior to planned surgery. The study aims to enroll about 30 patients between September 2025 and September 2027 and will collect safety and preliminary efficacy outcomes, including tumor response and surgical outcomes. Eligibility requires cT3-4 and/or node-positive disease confined to the mesorectum, tumor ≤10 cm from the anal verge, ECOG 0–1, and no prior anti-cancer or pelvic radiotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients who have a desire to preserve the anus and are willing to receive the entire course of neoadjuvant therapy.

  * Aged between 18 and 75 years, with no gender restrictions.

    * Diagnosed via pelvic MRI and rectoscopy with a tumor located ≤10 cm from the anal verge, with a clinical stage of cT3-4N0/+M0, and lymph nodes confined within the mesorectum.

      * Histologically diagnosed with rectal adenocarcinoma; genetic testing indicates MSS or MSI-L, or immunohistochemistry of tumor biopsy indicates pMMR (positive for MSH1, MSH2, MSH6, and PMS2 proteins).

        * ECOG performance status score of 0-1.

          ⑥ No prior antitumor therapy, immunotherapy, anti-angiogenic therapy, or pelvic radiotherapy before inclusion.

          ⑦ Laboratory tests must meet the following criteria: i. White blood cell count ≥3.5×10⁹/L, absolute neutrophil count ≥1.8×10⁹/L, platelet count ≥100×10⁹/L, and hemoglobin ≥100 g/L; ii. INR ≤1.5, and APTT ≤1.5 times the upper limit of normal, or partial thromboplastin time (PTT) ≤1.5 times the upper limit of normal; iii. Total bilirubin ≤1.25 times the upper limit of normal; ALT and AST ≤3 times the upper limit of normal; serum albumin ≥28 g/L; iv. 24-hour creatinine clearance rate ≥50 mL/min or serum creatinine ≤1.5 times the upper limit of normal.

          ⑧ Willing to participate in this study voluntarily, sign the informed consent form, and comply with the scheduled outpatient visits and related procedural requirements to complete follow-up.

Exclusion Criteria:

* In addition to a confirmed diagnosis of rectal cancer, there is a current or past history of active malignant tumors.

  * Patients with metastases to other sites indicated by preoperative staging.

    * Patients with suspicious positive lymph nodes in non-draining areas of the rectum, such as the internal and external iliac lymph nodes, as assessed by preoperative MRI or CT.

      * Patients requiring emergency surgery due to complications such as intestinal obstruction, intestinal perforation, or intestinal hemorrhage.

        * Patients with severe comorbid conditions and an estimated life expectancy of ≤5 years.

          * Patients with known allergies to any components in the study.

            ⑦ Patients who have received immunosuppressive or systemic corticosteroid therapy for immunosuppressive purposes within 30 days prior to the initiation of study treatment.

            ⑧ Patients who have received any other investigational drug treatment (including immunotherapy) or participated in another interventional clinical trial within 30 days prior to screening.

            ⑨ Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other severe diseases requiring combined treatment (including psychiatric disorders), and severe laboratory abnormalities.

            ⑩ Patients with congenital or acquired immunodeficiency (such as HIV infection).

            ⑪ Vulnerable populations, including individuals with psychiatric disorders, cognitive impairments, critically ill patients, minors, pregnant women, illiterate individuals, etc.

            ⑫ Other circumstances where, in the investigator's judgment, the patient is deemed unsuitable to participate in the clinical trial.

Where it's running

• The First Affiliated Hospital of Wenzhou Medical University
  Wenzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Yifei Pan, Master's Degree in Medicine
• Email: 13506641535@139.com
• Phone: 86 13506641535

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NeoCSR-Omics: CAPOX and Serplulimab Before or After Short-Course RT in Locally Advanced Rectal Cancer

  This trial tests whether giving CAPOX chemotherapy with the PD-1 blocker serplulimab before or after short-course radiotherapy helps people with locally advanced rectal cancer achieve complete clinical or pathological responses.

  Recruiting Phase 2 Chongqing University Cancer Hospital · Chongqing, Chongqing Municipality · NCT07898865

• First-line sequential AG and mFOLFOX with serplulimab and bevacizumab versus AG alone for advanced pancreatic cancer

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  Recruiting Phase 3 Zhejiang Cancer Hospital · Hangzhou, Zhejiang · NCT07235930

• Combining Bevacizumab and Serplulimab with a New Treatment for Malignant Ascites

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  Recruiting at 3 sites Phase 2 Sun Yat-sen University · Guangzhou, Guangdong and 2 other locations · NCT06433869

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• Combining Serplulimab and Bevacizumab with FOLFOX for Colorectal Cancer Treatment

  This study is testing if adding two new drugs to standard chemotherapy can help people with colorectal cancer that has spread to the liver live longer and have fewer chances of the cancer coming back after surgery.

  Recruiting Phase 2/3 Sun Yat-sen University · Guangzhou, Guangdong · NCT06280495

• Combining serplulimab with chemotherapy for treating colon cancer spread to the abdomen

  This study is testing if adding serplulimab to chemotherapy can help people with colon cancer that has spread to the abdomen feel better and live longer.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Huzhou, Zhejiang · NCT05742425

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.