Serplulimab Combined With CAPOX and Bevacizumab as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer

NCT07819604 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: XJYY-LL-FJ-030
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an exploratory study to evaluate the efficacy and safety of neoadjuvant therapy with serplulimab combined with CAPOX and bevacizumab for patients with locally advanced colorectal cancer. The primary endpoint is pathological complete response (pCR). Secondary efficacy endpoints include major pathological response (MPR), R0 resection rate, tumor down-staging, objective response rate (ORR), disease-free survival (DFS), and quality of life, to demonstrate clinical benefit of this combination regimen in the target patient population.

Conditions

Locally Advanced Colorectal Cancer

Keywords

Serplulimab; CAPOX; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR) Rate

  Percentage of patients who achieve pathological complete response, defined as no residual viable tumor cells in the resected surgical specimen.

  Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection)

Secondary Outcomes (5)

• Major Pathological Response (MPR) Rate

  Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection)

• R0 Resection Rate

  Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection)

• Tumor Down-staging Rate

  Up to 6 weeks after completion of neoadjuvant therapy (at surgical resection)

• Objective Response Rate (ORR)

  Up to 6 weeks after completion of neoadjuvant therapy (prior to surgical resection)

• Disease-Free Survival (DFS)

  Up to 36 months after surgical resection

Study Arms (1)

Serplulimab plus CAPOX and Bevacizumab Neoadjuvant Treatment

EXPERIMENTAL

Drug: Serplulimab; Drug: CAPOX; Drug: Bevacizumab

Interventions

Serplulimab DRUG

Anti-PD-1 monoclonal antibody, administered intravenously as neoadjuvant therapy.

Serplulimab plus CAPOX and Bevacizumab Neoadjuvant Treatment

CAPOX DRUG

Combination chemotherapy regimen consisting of capecitabine plus oxaliplatin, administered intravenously as neoadjuvant therapy.

Serplulimab plus CAPOX and Bevacizumab Neoadjuvant Treatment

Bevacizumab DRUG

Anti-VEGF monoclonal antibody, administered intravenously as neoadjuvant therapy.

Serplulimab plus CAPOX and Bevacizumab Neoadjuvant Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily provide written informed consent prior to screening.
• Male or female subjects aged ≥18 years.
• At least one measurable lesion per RECIST 1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Histologically or pathologically confirmed locally advanced rectal adenocarcinoma, cT3/cT4N+M0 stage per AJCC/UICC 8th edition, with distance from anal verge ≤10 cm. Diagnosis is confirmed by contrast-enhanced CT/MRI, supplemented by colonoscopy and diagnostic laparoscopy if necessary; no prior anti-tumor treatment.
• Scheduled for surgical resection following neoadjuvant therapy based on clinical staging.
• Expected survival of more than 3 months.
• No emergency indications such as bowel obstruction, bleeding or perforation.
• Adequate major organ function as follows (no blood transfusion, granulocyte-colony stimulating factor (G-CSF) or other hematopoietic growth factor support within 14 days prior to screening):
• Hematology: Absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L, white blood cell count ≥3.5×10⁹/L.
• Liver function: ALT and AST ≤2.5×ULN; total bilirubin ≤1.5×ULN (≤3×ULN for patients with Gilbert syndrome).
• Renal function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min.
• Coagulation function: APTT, INR, PT ≤1.5×ULN.

You may not qualify if:

• Prior anti-tumor therapy including chemotherapy, radiotherapy, hormonal therapy or molecular-targeted therapy.
• Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibodies, or other agents targeting T-cell co-stimulatory or immune-checkpoint pathways.
• History of other malignant tumors within 5 years or concurrent other malignancies, except for cured carcinoma in situ of cervix, non-melanoma skin cancer, or other malignancies with ≥5 years disease-free survival after curative treatment.
• Peripheral neuropathy ≥Grade 2 per NCI-CTCAE v5.0.
• Known active central nervous system metastases and/or carcinomatous meningitis.
• History of severe hypersensitivity reaction (NCI-CTCAE v5.0 ≥Grade 3) to anti-PD-1 monoclonal antibodies, other monoclonal antibodies, oxaliplatin, S-1 or related compounds.
• History of hereditary bleeding disorders or coagulopathy with high bleeding risk.
• Major surgical procedure within 4 weeks prior to screening.
• Not recovered from prior surgical complications with residual toxicity \>Grade 1 (NCI-CTCAE v5.0), excluding alopecia and fatigue.
• Requirement for immunosuppressive medication within 2 weeks before screening or during study treatment, except for:
• Intranasal, inhaled, topical or intra-articular corticosteroids.
• Physiological-dose systemic corticosteroids (≤10 mg/day prednisone or equivalent).
• Short-term (≤7 days) corticosteroids for prophylaxis or treatment of non-autoimmune allergic conditions.
• Active or history of recurrent autoimmune disease.
• History of interstitial lung disease or non-infectious pneumonitis.

Sponsors & Collaborators

• Xijing Hospital: lead

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Liu Hong

  Xijing Hospital of Digestive Diseases, Xijing Hospital, Air force Medical University, Changlexi ST 15, Shaanxi Province, 710032, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinqiang Liu

CONTACT

19929061886; ljq679@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 15, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2030
• Last Updated: September 15, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share