A Prospective, Single-center, Phase II Study of Neoadjuvant Serplulimab Plus XELOX and Bevacizumab in Locally Advanced Rectal Cancer

NCT07854964 | Not Yet Recruiting

• 1 other identifier: WN-K202603-16
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this clinical trial is to understand the treatment effects of serplulimab combined with XELOX and bevacizumab as neoadjuvant therapy for locally advanced rectal cancer.

1. 1.What is the effectiveness of this treatment plan for the treatment of locally advanced rectal cancer ?
2. 2.What is the safety of this treatment for locally advanced rectal cancer ? The type of this study was a single-arm study, and only the patients in the group of Serplulimab combined with XELOX and bevacizumab were observed.
3. 3.The patient underwent four cycles of neoadjuvant therapy with Serplulimab combined with XELOX and bevacizumab (each cycle lasting three weeks).
4. 4.Preoperative assessment: Imaging evaluation to be conducted within 2-4 weeks after completing neoadjuvant therapy.
5. 5.Timing of surgery: Perform surgery within 4-6 weeks after completing neoadjuvant therapy.
6. 6.Surgical method: Choose the appropriate surgical approach (total mesorectal excision, sphincter-preserving or non-sphincter-preserving) based on the tumour location and extent of descent.
7. 7.Pathological assessment

Conditions

Locally Advanced Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• pCR rate

  The pCR rate and its 95 % confidence interval were calculated

  At the time of surgical resection, 4 to 6 weeks after completion of neoadjuvant therapy'

Secondary Outcomes (5)

• safety analysis

  From first study drug administration through 30 days after surgery

• Analysis of objective remission rate

  Up to 6 weeks after completion of neoadjuvant therapy, prior to surgery

• R0 resection rate analysis

  On the day of surgery

• Analysis of anal preservation rate

  On the day of surgery

• MMR / MSI status and PD-L1 expression level

  Two weeks after operation

Study Arms (1)

Intervention group

EXPERIMENTAL

Serplulimab combined with bevacizumab plus XELOX (oxaliplatin + capecitabine) as neoadjuvant therapy for locally advanced rectal cancer

Drug: Serplulimab; Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine

Interventions

Serplulimab DRUG

Intravenous infusion, 300 mg, Day 1 of every 3-week cycle, neoadjuvant treatment

Intervention group

Bevacizumab DRUG

Intravenous infusion, 7.5 mg/kg, Day 1 of every 3-week cycle, neoadjuvant treatment

Intervention group

Oxaliplatin DRUG

Intravenous infusion, 130 mg/m², Day 1 of every 3-week cycle, XELOX regimen

Intervention group

Capecitabine DRUG

Oral administration, 1000 mg/m² twice daily, Day 1 to Day 14 of every 3-week cycle, XELOX regimen

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Written informed consent must be signed before any trial-related procedures are performed.
• \. Male or female, aged ≥18 years and ≤75 years.
• \. Histologically or pathologically confirmed rectal adenocarcinoma, with confirmed proficient mismatch repair (pMMR) or microsatellite stable (MSS) status; diagnosed as locally advanced rectal cancer according to AJCC 9th edition, with cTNM staging as cT2-4N1-3M0 based on contrast-enhanced CT/MRI, and the lesion assessed as resectable by the investigator.
• \. No prior systemic therapy for the current disease, including surgery, anti-tumor radiotherapy/chemotherapy, immunotherapy, etc.
• \. ECOG performance status 0-1.
• \. Expected survival \>6 months.
• \. Adequate organ function, meeting the following laboratory criteria:
• Absolute neutrophil count (ANC) ≥1.5×10\^9/L without granulocyte colony-stimulating factor support within the past 14 days;
• Platelet count ≥100×10\^9/L without blood transfusion within the past 14 days;
• Hemoglobin \>9 g/dL without blood transfusion or erythropoietin use within the past 14 days;
• Total bilirubin ≤1.5× upper limit of normal (ULN);
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN;
• Serum creatinine ≤1.5× ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 mL/min;
• Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN;
• Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or free T3) and free T4 within the normal range may also be enrolled;

You may not qualify if:

• Known squamous cell carcinoma, undifferentiated carcinoma, or other histologic types of colorectal cancer, or adenocarcinoma mixed with other histologic types.
• Known deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) status.
• Presence of unresectable factors, including unresectability due to tumor-related reasons, presence of surgical contraindications, or subject refusal to undergo surgery.
• Diagnosis of another malignancy other than colorectal cancer within 5 years prior to the first dose (excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ).
• Current participation in interventional clinical research treatment, or receipt of another investigational drug or use of an investigational device within 4 weeks prior to the first dose.
• Prior receipt of immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG3 antibodies, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, or any other treatment directed at tumor immuno-mechanisms.
• Severe cardiac disease or conditions, including but not limited to: a confirmed history of heart failure or systolic dysfunction (LVEF \<50%); uncontrolled high-risk arrhythmias, such as atrial tachycardia, resting heart rate \>100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or high-grade atrioventricular block (i.e., Mobitz II second-degree AV block or third-degree AV block).
• Poorly controlled hypertension (systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>100 mmHg).
• Inability to swallow, intestinal obstruction, or other factors affecting drug administration and absorption.
• Known hypersensitivity to any component of the study drug regimen; history of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
• Female patients who are pregnant, breastfeeding, or of childbearing potential with a positive baseline pregnancy test, or women of childbearing potential who are unwilling to use effective contraceptive methods throughout the trial and for at least 7 months after the last dose of study treatment.
• Presence of serious concomitant disease or other confounding conditions that would interfere with planned treatment, or any other condition that, in the investigator's opinion, makes the subject unsuitable for study participation.

Sponsors & Collaborators

• Tang-Du Hospital: lead

MeSH Terms

Interventions

Bevacizumab; Oxaliplatin; Capecitabine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Nan Wang, Ph.D

CONTACT

02984777431; wangnandoc@163.com

Nan Wang

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of the Department of General Surgery, Chief Physician, Professor

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): May 15, 2030
• Study Completion (Estimated): May 15, 2031
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share