Combination therapy for locally recurrent colorectal cancer

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

This study is testing a new combination of medications to see if it can help people with locally recurrent colorectal cancer who have already had surgery for their initial cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Changzheng Hospital (Academic / other)
• Drugs / interventions: Bevacizumab, Tislelizumab, chemotherapy, immunotherapy, prednisone
• Locations: 1 site (Shanghai)
• Trial ID: NCT06881537 on ClinicalTrials.gov

What this trial studies

This prospective, single-arm study investigates the efficacy and safety of a combination therapy using Capecitabine, Oxaliplatin, Bevacizumab, and Tislelizumab as neoadjuvant treatment for patients with locally recurrent colorectal cancer. The trial focuses on patients who have previously undergone radical surgery for primary colorectal cancer and are now facing recurrence. Participants will be assessed for measurable disease and must meet specific eligibility criteria regarding their health status and prior treatments.

Who should consider this trial

Good fit: Ideal candidates include patients with a history of primary colorectal cancer who have undergone R0 resection and are now diagnosed with locally recurrent adenocarcinoma.

Not a fit: Patients who have received any form of treatment for their cancer within the past month or those with distant metastasis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with locally recurrent colorectal cancer by providing a more effective neoadjuvant therapy option.

How similar studies have performed: While this approach combines established therapies, the specific combination and its application as neoadjuvant therapy for this condition may be novel and not extensively tested in prior studies.

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.

Where this trial is running

Shanghai

• Shanghai Changzheng Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Haiyang Zhou, MD

Conditions Locally Recurrent Colorectal Cancer