mFOLFOXIRI Plus Bevacizumab for Organ Preservation in Locally Advanced Rectal Cancer

NCT07817888 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2026ZSLYEC-671
• Study Type: interventional
• Target: 119
• Locations: 0 countries
• Sites: N/A

Brief Summary

Neoadjuvant mFOLFOXIRI plus bevacizumab may achieve tumor shrinkage and reduce micrometastases, offering a radiotherapy-free organ-preservation alternative for locally advanced rectal cancer. This phase II trial will enroll patients with stage II-III rectal cancer to receive six cycles of neoadjuvant mFOLFOXIRI plus bevacizumab, followed by watch-and-wait, local excision, or total mesorectal excision based on response.

Conditions

Phase 2 Study

Keywords

RECTAL CANCER; ORGAN PRESERVATION; FOLFOXIRI; BEVACIZUMAB

Outcome Measures

Primary Outcomes (1)

• 3-year Disease Free Survival

  From the enrollment to 3 years following enrollment

Study Arms (1)

FOLFOXIRI+BEVA

EXPERIMENTAL

Patients will receive neoadjuvant mFOLFOXIRI plus bevacizumab for 6 cycles, with 14 days per cycle.

Drug: FOLFOXIRI + Bevacizumab

Interventions

FOLFOXIRI + Bevacizumab DRUG

Oxaliplatin 85 mg/m² intravenous infusion over 180 minutes on day 1; irinotecan 150 mg/m² intravenous infusion over 90 minutes on day 1; leucovorin 400 mg/m² intravenous infusion over 120 minutes on day 1; 5-fluorouracil 2400 mg/m² continuous intravenous infusion over 46 hours; bevacizumab 5 mg/kg intravenous infusion over 30-90 minutes on day 1.

FOLFOXIRI+BEVA

Eligibility Criteria

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

You may qualify if:

• Sign the informed consent form and comply with the planned visits, study treatment, laboratory tests, and other trial procedures;
• Age 18-75 years;
• Histologically confirmed rectal adenocarcinoma;
• The lower edge of the rectal tumor is \<10 cm from the anal verge (as assessed by pelvic MRI);
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Willing to choose the "organ preservation" strategy according to the study protocol;
• Locally staged as cTNM stage II-III (T3-4 with any N, or any T with N1-2) by contrast-enhanced pelvic MRI;
• No prior antitumor therapy for colorectal cancer, including cytotoxic drugs, radiotherapy, molecular targeted therapy, immune checkpoint inhibitors, etc.;
• Adequate organ function as indicated by the following laboratory values obtained during the screening period: white blood cell count ≥3×10⁹/L, neutrophil count ≥1.5×10⁹/L, platelet count ≥75×10⁹/L, serum total bilirubin ≤1.5× upper limit of normal (ULN), aspartate aminotransferase or alanine aminotransferase ≤2.5× ULN, serum creatinine ≤1.5× ULN.

You may not qualify if:

• Distant metastasis (M1) confirmed by chest/abdominal/pelvic CT, pelvic MRI, or PET-CT;
• Bowel obstruction, active gastrointestinal bleeding, or perforation caused by the tumor;
• Tumor complicated by intestinal fistula or pelvic abscess;
• Concurrent malignant tumors of other organ systems (except malignancies that have been curatively treated with no recurrence for more than 5 years, or carcinoma in situ that can be cured by adequate treatment);
• Thrombotic or embolic events within 12 months prior to enrollment, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, or deep vein thrombosis;
• Within 12 months prior to enrollment, any of the following: myocardial infarction, severe/unstable angina, New York Heart Association (NYHA) class ≥ II cardiac dysfunction, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure;
• Tumors diagnosed as mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) by immunohistochemistry or PCR;
• Uncontrolled systemic infection or unexplained fever (\>38.5°C) within 2 weeks prior to enrollment;
• Concurrent presence of any of the following other diseases: human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness; poorly controlled diseases including but not limited to non-infectious pneumonitis, diabetes mellitus, hypertension, pulmonary fibrosis, acute pneumonia, aneurysm, and coagulation disorders; or any other disease that, in the investigator's opinion, may affect the assessment of study endpoints;
• Known or suspected allergy to the study drugs;
• Pregnant or lactating women;
• Patients with other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of study participation, interfere with study results, or who are considered unsuitable for participation by the investigator.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Zerong Cai, M.D.

CONTACT

86-020-38455325; caizer@126.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: September 8, 2026
• First Posted: September 14, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2031
• Last Updated: September 14, 2026

Record last verified: 2026-08