Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06881537

CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Locally Recurrent Colorectal Cancer

Led by Shanghai Changzheng Hospital · Updated on 2025-03-18

15

Participants Needed

1

Research Sites

212 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This prospective, single-arm study aims to investigate the efficacy and safety of CapeOX combined with Bevacizumab plus Anti-PD1 Antibody as neoadjuvant therapy for locally recurrent colorectal cancer

CONDITIONS

Official Title

CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Locally Recurrent Colorectal Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary colorectal cancer treated with radical surgery and confirmed adenocarcinoma with R0 resection
  • Postoperative adjuvant chemotherapy with Xelox or other first-line standard regimens
  • Clinically diagnosed with locally recurrent colorectal adenocarcinoma based on imaging and histology
  • No treatment including chemotherapy, targeted therapy, immunotherapy, or radiotherapy within the past month
  • Measurable disease according to RECIST 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • No distant metastasis confirmed by CT, MRI, or PET/CT
  • Adequate hematologic and organ function based on recent laboratory tests
  • Women of childbearing age must have a negative pregnancy test and agree to use effective contraception during treatment and for 60 days after
  • Life expectancy greater than 3 months
  • Signed and written informed consent
Not Eligible

You will not qualify if you...

  • Previous treatment with anti-PD1, anti-PDL1, anti-PDL2, or anti-CTLA4 antibodies
  • Intestinal obstruction or uncontrollable active bleeding requiring urgent treatment
  • Contraindications to Oxaliplatin, Capecitabine, Bevacizumab, or Tislelizumab
  • Hypersensitivity to monoclonal antibodies
  • Active autoimmune diseases
  • Uncontrolled pleural, pericardial effusion, or ascites
  • History of certain lung diseases or active pneumonia
  • Major surgery within 4 weeks before enrollment without full recovery
  • Active bleeding, abnormal coagulation, or use of anticoagulant therapy
  • Previous allogeneic stem cell or organ transplantation
  • Significant clinical or laboratory abnormalities affecting safety
  • Uncorrected electrolyte disturbances
  • HIV infection
  • Active hepatitis B or C
  • Pregnancy or lactation without contraception
  • Other malignancies within 5 years except certain skin and cervical cancers
  • Use of corticosteroids or immunosuppressants within 14 days before enrollment
  • Active tuberculosis or recent anti-TB treatment
  • Active infection or recent antibiotic treatment except prophylaxis
  • Recent vaccination with anti-infective vaccines within 4 weeks
  • Participation in other clinical trials within 4 weeks
  • Any other disease or condition that may affect safety, study reliability, or compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai Changzheng Hospital

Shanghai, China

Actively Recruiting

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Research Team

H

Haiyang Zhou, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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