Evaluation of the Efficacy and Safety of Bevacizumab Combined With PD-1 Monoclonal Antibody in Preoperative Neoadjuvant Therapy for MSS Colorectal Cancer With Liver Metastases

NCT06124729 | Unknown

• 1 other identifier: CRSYM202311
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluation of the Efficacy and Safety of Bevacizumab Combined With PD-1 Monoclonal Antibody in Preoperative Neoadjuvant Therapy for MSS Colorectal Cancer With Liver Metastases - a Single-center, Single-arm, Open-label Clinical Trail.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• cCR

  To evaluate whether neoadjuvant Bevacizumab Combined With PD-1 Monoclonal Antibody would significantly improve the Clinical complete response (cCR) proportion in MSS Colorectal Cancer With Liver Metastases

  20 weeks

Secondary Outcomes (4)

• R0 resection rate

  1 day

• pCR proportion

  20 weeks

• Major pathological response (MPR)

  20 weeks

• Disease-free survival (DFS) and overall survival (OS)

  5 years

Study Arms (1)

Bevacizumab Combined With PD-1 Monoclonal Antibody in Preoperative Neoadjuvant Therapy

Drug: Bevacizumab Combined With PD-1 Monoclonal Antibody

Interventions

Bevacizumab Combined With PD-1 Monoclonal Antibody DRUG

Bevacizumab Combined With PD-1 Monoclonal Antibody in Preoperative Neoadjuvant Therapy for MSS colorectal cancer with liver metastases

Bevacizumab Combined With PD-1 Monoclonal Antibody in Preoperative Neoadjuvant Therapy

Eligibility Criteria

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

Study Population

Patients with MSS colorectal cancer who have been diagnosed with liver metastases and are physically able to tolerate neoadjuvant chemotherapy.

You may qualify if:

• Men and women aged 18-75 years old;
• Histologically or radiographically proven colon or rectal adenocarcinoma with liver metastases；
• ECOG performance status score of 0 to 2；
• Clinical staged any T with liver metastases (M+);
• MSS status;
• Adequate haematological, hepatic, and renal function: neutrophil count ≥1.5×109 /L; platelet count ≥75×109 /L; serum total bilirubin ≤1.5×upper normal limits (UNL); aspartate aminotransferase ≤2.5×UNL; alanine aminotransferase ≤2.5×UNL; serum creatinine ≤1.5 x UNL.

You may not qualify if:

• MSI status;
• Colorectal cancer without liver metastases;
• Relapsed colorectal cancer;
• Complicated with active bleeding, perforation, or requiring emergency surgery;
• Previous systemic anticancer therapy for colorectal cancer disease;
• Any active or history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications;
• Patients with other active concurrent non-colorectal cancer;
• Patients with interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as: diabetes, hypertension, pulmonary fibrosis and acute pneumonia);
• Patients with any Grade 2 or above toxicity as classified by the common terminology criteria for adverse events (CTCAE) (version 5.0) (except for anemia, alopecia and skin pigmentation) which is induced by previous treatment and has not subside;
• Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti- cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-lymphocyte-associated Protein 4, CTLA-4) antibody Women in pregnancy or lactation;
• Known positive history or positive test for Human Immunodeficiency Virus or Acquired Immunodeficiency Syndrome (AIDS);
• History of known or suspected allergies to any related drugs used in the trial; Women who are pregnant or nursing.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Related Publications (1)

• Diaz LA Jr, Shiu KK, Kim TW, Jensen BV, Jensen LH, Punt C, Smith D, Garcia-Carbonero R, Benavides M, Gibbs P, de la Fourchardiere C, Rivera F, Elez E, Le DT, Yoshino T, Zhong WY, Fogelman D, Marinello P, Andre T; KEYNOTE-177 Investigators. Pembrolizumab versus chemotherapy for microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer (KEYNOTE-177): final analysis of a randomised, open-label, phase 3 study. Lancet Oncol. 2022 May;23(5):659-670. doi: 10.1016/S1470-2045(22)00197-8. Epub 2022 Apr 12.

  PMID: 35427471 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Yueming Sun, MD,PHD

CONTACT

02568306026; jssym@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: November 9, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share