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

NCT06881537 | Recruiting Phase 2

• 1 other identifier: ZHOUHAIYANG4
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Locally Recurrent Colorectal Cancer

Outcome Measures

Primary Outcomes (5)

• Objective response rate

  Percentage of patients who achieve partial response (PR) or complete response (CR)

  15 weeks

• R0 resection rate

  Percentage of patients who achieve R0 resection

  15 weeks

• Pathological complete response rate

  Percentage of patients who achieve pathological complete response (pCR) based on local investigator

  15 weeks

• Tumor regression grade (TRG)

  15 weeks

• Incidence of Treatment-Related Adverse Events

  Number of adverse events

  Until 30 days after the last treatment

Secondary Outcomes (6)

• Surgical complications

  Until 90 days after surgery

• Quality of life score (QoL score)

  Until 30 days after the last treatment

• Event free survival

  Up to 3 years

• Disease-free survival

  Up to 3 years

• One-year or two-year disease-free survival rate

  Up to 2 years

Study Arms (1)

CapeOx+ Bevacizumab + Tislelizumab as neoadjuvant treatment

EXPERIMENTAL

CapeOx: Capecitabine is given orally at 1000mg / m² twice a day from day1-14 every 3 weeks for 4 cycles and Oxaliplatin is given by intravenous infusion at 130mg / m² on Day 1 every 3 weeks for 4 cycles; Bevacizumab：Bevacizumab is given intravenously at 7.5mg/kg on day 1 every 3 weeks for 4 cycles; Tislelizumab：Tislelizumab is given intravenously at 200 mg on day 1 every 3 weeks for 4 cycles

Drug: Capecitabine; Drug: Oxaliplatin; Drug: Bevacizumab; Drug: Tislelizumab

Interventions

Capecitabine DRUG

Capecitabine is given orally at 1000mg / m² twice a day from day1-14 every 3 weeks for 4 cycles

CapeOx+ Bevacizumab + Tislelizumab as neoadjuvant treatment

Oxaliplatin DRUG

Oxaliplatin is given by intravenous infusion at 130mg / m² on Day 1 every 3 weeks for 4 cycles

CapeOx+ Bevacizumab + Tislelizumab as neoadjuvant treatment

Bevacizumab DRUG

Bevacizumab is given intravenously at 7.5mg/kg on day 1 every 3 weeks for 4 cycles

CapeOx+ Bevacizumab + Tislelizumab as neoadjuvant treatment

Tislelizumab DRUG

Tislelizumab is given intravenously at 200 mg on day 1 every 3 weeks for 4 cycles

CapeOx+ Bevacizumab + Tislelizumab as neoadjuvant treatment

Eligibility Criteria

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

You may qualify if:

• Primary colorectal cancer underwent radical surgery, histologically confirmed as adenocarcinoma and achieved R0 resection, and postoperative adjuvant chemotherapy with Xelox or other first-line standard regimens.
• Based on the imaging and histological examination results, the patient was clinically assessed and diagnosed with locally recurrent colorectal adenocarcinoma.
• The patients did not receive any treatment, including chemotherapy, targeted therapy, immunotherapy, or radiotherapy, within the past month.
• Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) 0-1.
• Absence of distant metastasis confirmed by CT, MRI or PET/CT.
• Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained within 7 days before first dose. Absolute neutrophil count ≥1500/mm3, platelet ≥100,000/mm3, Hb ≥10g/dl, serum creatinine ≤1.5 times ULN, creatinine clearance rate ≥50mL/min, ALT and AST ≤2.5 times ULN, INR or aPTT ≤1.5 times ULN (INR ≤2 times ULN and aPTT in normal range for patients who are on prophylactic anticoagulant therapy within 14 days before study treatment), total bilirubin level ≤2 times ULN (within 7 days before study treatment).
• Women of childbearing age should confirm that serum pregnancy test is negative and agree to use effective contraceptive methods during study treatment and the following 60 days.
• Life expectancy\> 3 months
• Signed and written informed consent

You may not qualify if:

• Previously received anti-PD1 or anti-PDL1 or anti-PDL2 or anti-CTLA4.
• Intestinal obstruction or uncontrollable active bleeding caused by the tumor requiring urgent treatment.
• Contraindications of Oxaliplatin, Capecitabine, Bevacizumab, and Tislelizumab.
• Hypersensitivity to other monoclonal antibodies.
• Any active, known or suspected autoimmune disease.
• Uncontrolled pleural effusion, pericardial effusion, or ascites to a moderate or greater extent.
• History of one of the following diseases: idiopathic pulmonary fibrosis, organized pneumonia (eg. bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia and interstitial pneumonia, or evidence of active pneumonia through enhanced chest CT screening.
• Major surgery within 4 weeks before enrollment and haven't fully recovered from the previous surgery.
• Active bleeding or abnormal coagulation (aPTT \>43s or INR \>1.5 times ULN), or having a tendency to bleed or receiving thrombolytic or anticoagulant therapy.
• Previously received allogeneic stem cell or parenchymal organ transplantation.
• Any significant clinical or laboratory abnormality that the investigator considers to influence the safety assessment, eg. uncontrolled active infection, uncontrolled diabetes, hypertension that cannot be reduced to normal range with monotherapy, grade II or above peripheral neuropathy, congestive heart failure, heart disease (class II or higher) as defined by the New York College of Cardiology, myocardial infarction within 3 months prior to enrollment, unstable arrhythmias, unstable angina pectinis, chronic kidney disease, abnormal thyroid function and previous or co-existing malignancies.
• History of uncorrected serum electrolyte disturbances such as potassium, calcium and magnesium.
• HIV infection.
• Active hepatitis B or hepatitis C.
• Pregnancy or lactation period, or unwilling to use contraception during the trial.

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Capecitabine; Oxaliplatin; Bevacizumab; tislelizumab

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Haiyang Zhou, MD

CONTACT

+86 81885615; haiyang1985_1@aliyun.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: March 12, 2025
• First Posted: March 18, 2025
• Study Start: June 1, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)