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

NCT ID: NCT06881537

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2028-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CapeOx+ Bevacizumab + Tislelizumab as neoadjuvant treatment

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

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

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

Oxaliplatin

Intervention Type: DRUG

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

Bevacizumab

Intervention Type: DRUG

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

Tislelizumab

Intervention Type: DRUG

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

Interventions

Capecitabine

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

Intervention Type: DRUG

Oxaliplatin

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

Intervention Type: DRUG

Bevacizumab

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

Intervention Type: DRUG

Tislelizumab

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• With other malignancy within 5 year, except cervical carcinoma in situ, basal or squamous skin cancer, local prostatic carcinoma and ductal carcinoma in situ.
• Use corticosteroids (dose of prednisone or similar drugs> 10mg/day) or other immunosuppressive agents within 14 days before enrollment.
• Patients with active tuberculosis (TB) who are receiving anti-TB treatment or have received anti-TB treatment within 1 year.
• Active infection, or treatment with oral or intravenous antibiotics within the first 2 weeks prior to neoadjuvant therapy, except prophylactic administration.
• Anti-infective vaccine (eg. influenza vaccine, varicella vaccine, etc.) injection within 4 weeks before neoadjuvant therapy.
• Previous participation in other clinical trials within 4 weeks before neoadjuvant therapy.
• Any other disease, metabolic disorder, abnormal physical examination or abnormal laboratory results that may constrain the use of trial drug, or affect the reliability of study results, or lead to high risk of treatment complications, or affect patient compliance.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Changzheng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Changzheng Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Haiyang Zhou, MD

Role: CONTACT

haiyang1985_1@aliyun.com

+86 81885615

Facility Contacts

Haiyang Zhou, MD

Role: primary

haiyang1985_1@aliyun.com

+86 81885615

Other Identifiers

ZHOUHAIYANG4

Identifier Type: -

Identifier Source: org_study_id