mFOLFOXIRI Plus Bevacizumab for Organ Preservation in Locally Advanced Rectal Cancer (FOBEAR-ii)

September 8, 2026 updated by: Sixth Affiliated Hospital, Sun Yat-sen University

Neoadjuvant mFOLFOXIRI Plus Bevacizumab for Organ Preservation in Locally Advanced Rectal Cancer: A Singe-arm Phase II Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Wait and watch following neoadjuvant chemoradiotherapy is a effective organ preservation strategy in locally advanced rectal cancer. However, radiotherapy is associated with significant pelvic organ toxicity and does not reduce the risk of distant metastasis. Neoadjuvant mFOLFOXIRI plus bevacizumab can achieve effective tumor shrinkage and might simultaneously reduce micrometastatic disease. On this basis, we here propose an active organ-preservation strategy using neoadjuvant mFOLFOXIRI plus bevacizumab in locally advanced rectal cancer. This multicenter, single-arm, phase II trial will enroll patients with stage II-III rectal cancer to receive six cycles of neoadjuvant mFOLFOXIRI plus bevacizumab. Based on clinical response after treatment, patients will undergo watch-and-wait, local excision, or total mesorectal excision. Post-treatment surveillance will combine imaging with tumor-informed circulating tumor DNA (ctDNA) monitoring. The primary endpoint is the 3-year disease-free survival rate. This study is expected to provide clinical evidence on the safety and efficacy of a radiotherapy-free active watch-and-wait strategy for rectal cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
119

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Zerong Cai, M.D.
  • Phone Number: 86-020-38455325
  • Email: caizer@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FOLFOXIRI+BEVA
Patients will receive neoadjuvant mFOLFOXIRI plus bevacizumab for 6 cycles, with 14 days per cycle.
Drug: FOLFOXIRI + Bevacizumab
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
3-year Disease Free Survival
Time Frame: From the enrollment to 3 years following enrollment
From the enrollment to 3 years following enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026ZSLYEC-671

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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