Preoperative Nivolumab Plus Bevacizumab Combined With Chemotherapy Before Surgery in Patients With pMMR/MSS Colorectal Cancer Liver Metastases

Safety and Efficacy of Nivolumab Combined With CAPOX Plus Bevacizumab as Neoadjuvant Treatment of pMMR/MSS Colorectal Cancer Liver Metastases Patients：a Single-arm, Phase II, Prospective Study

NCT05588297•Shanghai Changzheng Hospital

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Summary

This prospective, single-arm study aims to investigate the safety and efficacy of Nivolumab plus bevacizumab and chemotherapy as neoadjuvant treatment in pMMR/MSS Colorectal cancer liver metastases patients

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥18 years old and ≤75 years old
•On the basis of data from the literature, we defined liver metastases as B/U if at least one of the following was present: more than four liver metastases, involvement of the hepatic artery or portal vein, or involvement of the biliary duct. A trained radiologist reviewed radiologic images (computed tomography or magnetic resonance imaging scans of the abdomen) taken before the conversion chemotherapy to assess the resectability criteria.
•Immunohistochemistry and/or genetic testing confirmed pMMR/MSS
•Initial diagnosed or recurrent patients will be accepted, patients with recurrence should not have received any treatment include chemotherapy, targeted therapy or immunotherapy within 1 month or radiotherapy within 1 year
•Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria and haven't received any local treatment.
•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
+1 more criteria

Exclusion Criteria

•Previously received anti-PD1 or anti-PDL1 or anti-PDL2 or anti-CTLA4.
•Uncontrolled active bleeding from the primary tumor or intestinal obstruction.
•Contraindications of bevacizumab
•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.
+12 more criteria

Key Dates

Start Date

October 1, 2022

Primary Completion Date

March 1, 2023

Completion Date

October 1, 2025

Last Updated

October 20, 2022

Enrollment

ESTIMATED participants

Conditions

Colorectal Cancer Liver Metastases

Interventions

CapOx(Capecitabine+ Oxaliplatin)

DRUG

Bevacizumab

DRUG

Nivolumab

DRUG

Contacts

Haiyang Zhou, MD

CONTACT

+86 13764515639 haiyang1985_1@aliyun.com

Exosome-derived Extrahepatic Metastasis Detection By Liquid Biopsy In Colorectal Cancer Liver Metastases

NCT07224724

Colorectal Cancer Liver Metastases (CRLM)Metastatic Colorectal Carcinoma (mCRC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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