Phase 2 StudyPhase 2FOBEAR-iiNCT07817888
mFOLFOXIRI Plus Bevacizumab for Organ Preservation in Locally Advanced Rectal Cancer
A Phase 2 study testing FOLFOXIRI + Bevacizumab in people with Phase 2 Study, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
Neoadjuvant mFOLFOXIRI plus bevacizumab may achieve tumor shrinkage and reduce micrometastases, offering a radiotherapy-free organ-preservation alternative for locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Phase 2 Study
- What is being tested?
- FOLFOXIRI + Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Sep 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Phase 2 Study
- Being tested
- FOLFOXIRI + Bevacizumab
- Keywords
- RECTAL CANCER, ORGAN PRESERVATION, FOLFOXIRI, BEVACIZUMAB
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOXIRI + BevacizumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| FOLFOXIRI+BEVA | Experimental | Patients will receive neoadjuvant mFOLFOXIRI plus bevacizumab for 6 cycles, with 14 days per cycle. Receives: Drug: FOLFOXIRI + Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year Disease Free Survival
Measured: From the enrollment to 3 years following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phase 2 StudyStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817888
- Sponsor's protocol ID
- 2026ZSLYEC-671
- Acronym
- FOBEAR-ii
- Status last verified
- Aug 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant mFOLFOXIRI Plus Bevacizumab for Organ Preservation in Locally Advanced Rectal Cancer: A Singe-arm Phase II Study
- ClinicalTrials.gov ID
- NCT07817888
- Acronym / sponsor ID
- FOBEAR-ii / 2026ZSLYEC-671
- Conditions
- Phase 2 Study
- Keywords
- RECTAL CANCER, ORGAN PRESERVATION, FOLFOXIRI, BEVACIZUMAB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFOXIRI+BEVA | Experimental | Drug: FOLFOXIRI + BevacizumabPatients will receive neoadjuvant mFOLFOXIRI plus bevacizumab for 6 cycles, with 14 days per cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOLFOXIRI + BevacizumabOxaliplatin 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. | Drug | FOLFOXIRI+BEVA |
Primary outcome
3-year Disease Free Survival
Time frame: From the enrollment to 3 years following enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFOXIRI + Bevacizumab in people with Phase 2 Study, run by Sixth Affiliated Hospital, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zerong Cai, M.D. (86-020-38455325, caizer@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Disease Free Survival (time frame: From the enrollment to 3 years following enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.