Rectal CancerPhase 3FOBEARNCT04215731
Neoadjuvant mFOLFOXIRI Plus Bevacizumab in Patients With High-Risk Locally Advanced Rectal Cancer
A Phase 3 study testing Neoadjuvant chemotherapy with mFOLFOXIRI plus bevacizumab, Restaging and Concomitant Chemoradiotherapy in people with Rectal Cancer, run by Yanhong Deng at 1 site in China.
Trial summary
Multimodality treatment that comprises preoperative fluoropyrimidine with concurrent radiotherapy followed by total mesorectal excision (TME) surgery and adjuvant fluoropyrimidine-based chemotherapy is recommended as a standard treatment of patients with stage II/III rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Neoadjuvant chemotherapy with mFOLFOXIRI plus bevacizumab, Restaging and Concomitant Chemoradiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 582 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2020to 1 Jun 2029
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent.
- Male or female subjects > 18 years < 70 of age.
- Histological or cytological documentation of adenocarcinoma of the rectal (<12 cm from the anal verge).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Evaluated by pelvic contrast-enhanced MRI as having high-risk locally advanced disease: cT3 with mesorectal fascia involvement, or cT4a/b, or positive lateral lymph nodes (TNM staging reference provided).
- No prior systemic anti-cancer therapy for colorectal cancer, including cytotoxic drugs, immune checkpoint inhibitors, molecular targeted therapy, or endocrine therapy.
- Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment
- Willing and able to comply with the study protocol and visit schedule.
Who cannot join
- Evidence of distant metastasis (M1) confirmed by systemic CT, MRI, or PET-CT (at minimum including chest, abdomen, and pelvis).
- Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization.
- Complete intestinal obstruction, active bleeding, or perforation requiring emergency surgery.
- Tumor invasion into the small intestine, or presence of intestinal fistula (including but not limited to rectovesical or rectovaginal fistula), or abscess.
- Previous or concurrent other active malignancies, except for malignancies treated with curative intent and disease-free for >5 years, or adequately treated carcinoma in situ.
- Prior pelvic radiotherapy, or any anti-cancer therapy (chemotherapy, targeted therapy, hormonal therapy, immunotherapy, biologic therapy, etc.) within 12 months prior to enrollment.
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- History of thromboembolic events within 12 months prior to enrollment, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, or deep vein thrombosis.
- Any of the following within 12 months prior to enrollment: myocardial infarction, severe/unstable angina, NYHA Class II or greater cardiac dysfunction, clinically significant supraventricular or ventricular arrhythmia, or symptomatic congestive heart failure.
- Diagnosis of dMMR or MSI-High tumor by immunohistochemistry or PCR testing.
- Current or within 2 weeks prior to enrollment: therapeutic antiplatelet therapy or high-dose anticoagulant therapy.
- Major surgery (e.g., laparotomy, thoracotomy, visceral resection via laparoscopy) or severe trauma within 2 months prior to enrollment (except for colostomy performed prior to enrollment; surgical incision must be fully healed before enrollment).
- Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
- Presence of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, acute pneumonia, aneurysm, coagulation disorders, etc.).
- Untreated active hepatitis (Hepatitis B, defined as HBV-DNA ≥500 IU/mL; Hepatitis C, defined as HCV-RNA above the lower limit of detection of the assay) or co-infection with HBV and HCV.
- Subjects with known allergy to the study drugs or to any of its excipients.
- Breast- feeding or pregnant women.
- Any other severe physical or mental illness or abnormal laboratory finding that may increase the risk associated with study participation, interfere with study results, or make the patient unsuitable for the study in the investigator's judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Yanhong Deng, MD, 008613925106525, 13925106525@163.com
About this study
Official title: Neoadjuvant mFOLFOXIRI Plus Bevacizumab Versus Induction FOLFOX Followed by Concomitant Chemoradiotherapy in Patients With High-Risk Locally Advanced Rectal Cancer: Multicenter Randomized Phase III Trial
Multimodality treatment that comprises preoperative fluoropyrimidine with concurrent radiotherapy followed by total mesorectal excision (TME) surgery and adjuvant fluoropyrimidine-based chemotherapy is recommended as a standard treatment of patients with stage II/III rectal cancer. However, the main target of radiotherapy is local control but no improvement in disease-free survival (DFS) or overall survival (OS) has been shown with this treatment strategy, which leaves approximately 30% of patients in whom distant metastases will develop. Moreover, the short- and long-term adverse effects of radiotherapy such as chronic pain, faecal incontinence and urogenital/anal dysfunction are associated with poor quality of life.
Neadajuvant chemotherpay (NACT) alone has been proposed instead of preoperative chemoradiotherapy (CRT) with the aim of elimination of potential micrometastasis as early as possible while avoiding the adverse effects of radiotherapy, without jeopardizing local control.
Read more
Evidence from the UK CR07 trial suggests that, without RT, a local recurrence rate of 5% (27/543) can be achieved if a complete mesorectal excision is carried out with a negative CRM. A small single-center phase II pilot trial treated patients with stage II or III rectal cancer with induction FOLFOX/bevacizumab chemotherapy followed by CRT only in those with stable or progressive disease and resection in all patients. All 32 of the participants had an R0 resection, and the 4-year DFS was 84%. Another phase II trial, which included 60 patients with stage II/III rectal cancer, assessed the R0 resection rate after FOLFOX plus either bevacizumab or cetuximab. An R0 resection was achieved in 98.3% of the participants, and the pathologic complete response rate was 16.7%. The phase III FOWARC trial, compared neoadjuvant therapy with and without radiation and found that perioperative mFOLFOX6 alone led to a similar downstaging rate as fluorouracil-radiotherapy, and no significant difference in outcomes was found between mFOLFOX6 without radiotherapy and 5-FU- radiotherapy.
On the basis of the results of these trials, The investigators hypothesized that radiotherapy could be selectively omitted for patients who respond to NACT alone. The results of TRIBE showed that FOLFOXIRI plus bevacizumab yield a high objective response rate (ORR) (65%), early tumor shrinkage (ETS) (62.7%) and depth of response (DoR) (43.4%) in patients with metastatic colorectal cancer.
The investigators were motivated to investigate this triplet-drugs chemotherpay plus bevacizumab both by the possibility of avoiding the toxicities of radiation without compromising local control, and the possibility that earlier introduction of intensive systemic therapy might achieve rapid tumor shrinkage, and improve distant control.
The investigators conducted this phase III trial to compare neoadjuvant mFOLFOXIRI plus bevacizumab with selective radiotherapy with induction FOLFOX followed by concomitant chemoradiotherapy in patients with high-risk locally advanced rectal cancer.
Read the detailed description
This trial is a two-arm, multicenter, open labelled, prospective, randomized phase III studies. Eligible patients with high-risk locally advanced rectal cancer patients (cT3 with any MRF involved, any cT4a/b or lateral node positive) will be randomly assigned, in a 1:1 ratio, to receive either neoadjuvant mFOLFOXIRI plus bevacizumab with selective radiotherapy or induction FOLFOX followed by concomitant chemoradiotherapy.
- Conditions
- Rectal Cancer
- Being tested
- Neoadjuvant chemotherapy with mFOLFOXIRI plus bevacizumab, Restaging, Concomitant Chemoradiotherapy, Surgery, Chemoradiotherapy (only when patients with MRF involved or ycT4a/b by restaging)
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemotherapy with mFOLFOXIRI plus bevacizumabDrug
Also called Oxaliplatin, Irinotecan, 5-Fluorouracil, Leucovorin
Bevacizumab (5 mg/kg on day 1) plus mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 4 cycles and mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 2 cycles
RestagingProcedure or surgery
Restaging by pelvic magnetic resonance imaging (MRI)
Concomitant ChemoradiotherapyRadiation
Concomitant chemoradiotherapy (preoperative radiotherapy consisted of 50 Gy in 25 fractions, and concurrent with capecitabine at a fixed dose of 825 mg/m2 twice daily on days 1 to 5 for 5 weeks)
SurgeryProcedure or surgery
Radical surgery (TME or more extended surgery)
Chemoradiotherapy (only when patients with MRF involved or ycT4a/b by restaging)Radiation
Chemoradiotherapy (preoperative radiotherapy consisted of 50 Gy in 25 fractions, and concurrent with capecitabine at a fixed dose of 825 mg/m2 twice daily on days 1 to 5 for 5 weeks)
Induction chemotherpay with FOLFOXDrug
Also called Oxaliplatin, 5-Fluorouracil, Leucovorin
mFOLFOX6 (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by bolus 5-fluorouracil 400 mg/m2 and 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| mFOLFOXIRI Plus Bevacizumab | Experimental | Patients will receive neoadjuvant mFOLFOXIRI plus bevacizumab once every two weeks for 4 cycles and the same mFOLFOXIRI for 2 cycles. After completing all 6 cycles chemotherapy, the patient will have an MRI scan to examine the tumor. If MRI restaging is ycT4a/b, or MRF involved, the patient will receive concomitant chemoradiotherapy (preoperative radiotherapy consisted of 50 Gy in 25 fractions, and concurrent with capecitabine at a fixed dose of 825 mg/m2 twice daily on days 1 to 5 for 5 weeks). If MRI restaging is ycT0-3 and MRF negative, then the patient will proceed directly to surgery. Receives: Drug: Neoadjuvant chemotherapy with mFOLFOXIRI plus bevacizumab; Procedure: Restaging; Procedure: Surgery; Radiation: Chemoradiotherapy (only when patients with MRF involved or ycT4a/b by restaging) |
| Induction FOLFOX Followed by Concomitant Chemoradiotherapy | Active comparator | Patients will receive induction FOLFOX chemotherapy for 4 cycles and followed by concomitant chemoradiotherapy (preoperative radiotherapy consisted of 50 Gy in 25 fractions, and concurrent with capecitabine at a fixed dose of 825 mg/m2 twice daily on days 1 to 5 for 5 weeks), then the patient will proceed to surgery. Receives: Radiation: Concomitant Chemoradiotherapy; Procedure: Surgery; Drug: Induction chemotherpay with FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Defined as the time from randomization to relapse or death, whichever occurred first.
Measured: up to 3 years
Secondary outcomes (6)
R0 resection rate
R0 resection defined as complete tumor resection with all margins being negative.
Measured: up to 3 years
Pathologic complete response
Measured: up to 3 years
Overall survival (OS)
Defined as the time from randomization to death from any cause.
Measured: up to 5 years
Toxicity assessed using the NCI common toxicity criteria, version 4.0.
The grade of toxicity will be assessed using the NCI common toxicity criteria, version 5.0.
Measured: up to 5 years
Postoperative morbidity
Measured: up to 5 years
local recurrence rate
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start27 Mar 2020
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 582 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanhong Deng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanhong Deng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215731
- Sponsor's protocol ID
- GIHSYSU-17
- Acronym
- FOBEAR
- Status last verified
- Feb 2026
- First submitted
- 29 Dec 2019
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant mFOLFOXIRI Plus Bevacizumab Versus Induction FOLFOX Followed by Concomitant Chemoradiotherapy in Patients With High-Risk Locally Advanced Rectal Cancer: Multicenter Randomized Phase III Trial
- ClinicalTrials.gov ID
- NCT04215731
- Acronym / sponsor ID
- FOBEAR / GIHSYSU-17
- Conditions
- Rectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 582 participants (estimated)
- Lead sponsor
- Yanhong DengUniversity, hospital or other
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 2 Jan 2020 (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.
Multimodality treatment that comprises preoperative fluoropyrimidine with concurrent radiotherapy followed by total mesorectal excision (TME) surgery and adjuvant fluoropyrimidine-based chemotherapy is recommended as a standard treatment of patients with stage II/III rectal cancer. However, the main target of radiotherapy is local control but no improvement in disease-free survival (DFS) or overall survival (OS) has been shown with this treatment strategy, which leaves approximately 30% of patients in whom distant metastases will develop. Moreover, the short- and long-term adverse effects of radiotherapy such as chronic pain, faecal incontinence and urogenital/anal dysfunction are associated with poor quality of life.
Neadajuvant chemotherpay (NACT) alone has been proposed instead of preoperative chemoradiotherapy (CRT) with the aim of elimination of potential micrometastasis as early as possible while avoiding the adverse effects of radiotherapy, without jeopardizing local control.
Evidence from the UK CR07 trial suggests that, without RT, a local recurrence rate of 5% (27/543) can be achieved if a complete mesorectal excision is carried out with a negative CRM. A small single-center phase II pilot trial treated patients with stage II or III rectal cancer with induction FOLFOX/bevacizumab chemotherapy followed by CRT only in those with stable or progressive disease and resection in all patients. All 32 of the participants had an R0 resection, and the 4-year DFS was 84%. Another phase II trial, which included 60 patients with stage II/III rectal cancer, assessed the R0 resection rate after FOLFOX plus either bevacizumab or cetuximab. An R0 resection was achieved in 98.3% of the participants, and the pathologic complete response rate was 16.7%. The phase III FOWARC trial, compared neoadjuvant therapy with and without radiation and found that perioperative mFOLFOX6 alone led to a similar downstaging rate as fluorouracil-radiotherapy, and no significant difference in outcomes was found between mFOLFOX6 without radiotherapy and 5-FU- radiotherapy.
On the basis of the results of these trials, The investigators hypothesized that radiotherapy could be selectively omitted for patients who respond to NACT alone. The results of TRIBE showed that FOLFOXIRI plus bevacizumab yield a high objective response rate (ORR) (65%), early tumor shrinkage (ETS) (62.7%) and depth of response (DoR) (43.4%) in patients with metastatic colorectal cancer.
The investigators were motivated to investigate this triplet-drugs chemotherpay plus bevacizumab both by the possibility of avoiding the toxicities of radiation without compromising local control, and the possibility that earlier introduction of intensive systemic therapy might achieve rapid tumor shrinkage, and improve distant control.
The investigators conducted this phase III trial to compare neoadjuvant mFOLFOXIRI plus bevacizumab with selective radiotherapy with induction FOLFOX followed by concomitant chemoradiotherapy in patients with high-risk locally advanced rectal cancer.
Detailed description
This trial is a two-arm, multicenter, open labelled, prospective, randomized phase III studies. Eligible patients with high-risk locally advanced rectal cancer patients (cT3 with any MRF involved, any cT4a/b or lateral node positive) will be randomly assigned, in a 1:1 ratio, to receive either neoadjuvant mFOLFOXIRI plus bevacizumab with selective radiotherapy or induction FOLFOX followed by concomitant chemoradiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mFOLFOXIRI Plus Bevacizumab | Experimental | Drug: Neoadjuvant chemotherapy with mFOLFOXIRI plus bevacizumab, Procedure: Restaging, Procedure: Surgery, Radiation: Chemoradiotherapy (only when patients with MRF involved or ycT4a/b by restaging)Patients will receive neoadjuvant mFOLFOXIRI plus bevacizumab once every two weeks for 4 cycles and the same mFOLFOXIRI for 2 cycles. After completing all 6 cycles chemotherapy, the patient will have an MRI scan to examine the tumor. If MRI restaging is ycT4a/b, or MRF involved, the patient will receive concomitant chemoradiotherapy (preoperative radiotherapy consisted of 50 Gy in 25 fractions, and concurrent with capecitabine at a fixed dose of 825 mg/m2 twice daily on days 1 to 5 for 5 weeks). If MRI restaging is ycT0-3 and MRF negative, then the patient will proceed directly to surgery. |
| Induction FOLFOX Followed by Concomitant Chemoradiotherapy | Active comparator | Radiation: Concomitant Chemoradiotherapy, Procedure: Surgery, Drug: Induction chemotherpay with FOLFOXPatients will receive induction FOLFOX chemotherapy for 4 cycles and followed by concomitant chemoradiotherapy (preoperative radiotherapy consisted of 50 Gy in 25 fractions, and concurrent with capecitabine at a fixed dose of 825 mg/m2 twice daily on days 1 to 5 for 5 weeks), then the patient will proceed to surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing and able to provide written informed consent.
- Male or female subjects > 18 years < 70 of age.
- Histological or cytological documentation of adenocarcinoma of the rectal (<12 cm from the anal verge).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Evaluated by pelvic contrast-enhanced MRI as having high-risk locally advanced disease: cT3 with mesorectal fascia involvement, or cT4a/b, or positive lateral lymph nodes (TNM staging reference provided).
Key exclusion criteria (17 listed)
- Evidence of distant metastasis (M1) confirmed by systemic CT, MRI, or PET-CT (at minimum including chest, abdomen, and pelvis).
- Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization.
- Complete intestinal obstruction, active bleeding, or perforation requiring emergency surgery.
- Tumor invasion into the small intestine, or presence of intestinal fistula (including but not limited to rectovesical or rectovaginal fistula), or abscess.
- Previous or concurrent other active malignancies, except for malignancies treated with curative intent and disease-free for >5 years, or adequately treated carcinoma in situ.
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 |
|---|---|---|
| Neoadjuvant chemotherapy with mFOLFOXIRI plus bevacizumabAlso: Oxaliplatin, Irinotecan, 5-Fluorouracil, LeucovorinBevacizumab (5 mg/kg on day 1) plus mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 4 cycles and mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 2 cycles | Drug | mFOLFOXIRI Plus Bevacizumab |
| RestagingRestaging by pelvic magnetic resonance imaging (MRI) | Procedure or surgery | mFOLFOXIRI Plus Bevacizumab |
| Concomitant ChemoradiotherapyConcomitant chemoradiotherapy (preoperative radiotherapy consisted of 50 Gy in 25 fractions, and concurrent with capecitabine at a fixed dose of 825 mg/m2 twice daily on days 1 to 5 for 5 weeks) | Radiation | Induction FOLFOX Followed by Concomitant Chemoradiotherapy |
| SurgeryRadical surgery (TME or more extended surgery) | Procedure or surgery | Induction FOLFOX Followed by Concomitant Chemoradiotherapy, mFOLFOXIRI Plus Bevacizumab |
| Chemoradiotherapy (only when patients with MRF involved or ycT4a/b by restaging)Chemoradiotherapy (preoperative radiotherapy consisted of 50 Gy in 25 fractions, and concurrent with capecitabine at a fixed dose of 825 mg/m2 twice daily on days 1 to 5 for 5 weeks) | Radiation | mFOLFOXIRI Plus Bevacizumab |
| Induction chemotherpay with FOLFOXAlso: Oxaliplatin, 5-Fluorouracil, LeucovorinmFOLFOX6 (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by bolus 5-fluorouracil 400 mg/m2 and 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 4 cycles | Drug | Induction FOLFOX Followed by Concomitant Chemoradiotherapy |
Primary outcome
Disease-free survival
Time frame: up to 3 years
Defined as the time from randomization to relapse or death, whichever occurred first.
6 secondary outcomes
R0 resection rate
Time frame: up to 3 years
Pathologic complete response
Time frame: up to 3 years
Overall survival (OS)
Time frame: up to 5 years
Toxicity assessed using the NCI common toxicity criteria, version 4.0.
Time frame: up to 5 years
Postoperative morbidity
Time frame: up to 5 years
local recurrence rate
Time frame: up to 3 years
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 3 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neoadjuvant chemotherapy with mFOLFOXIRI plus bevacizumab, Restaging and Concomitant Chemoradiotherapy in people with Rectal Cancer, run by Yanhong Deng at 1 site in China.
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 8 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xiaojian Wu, MD (02038389762, wuxjian@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: up to 3 years). 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 3 Mar 2026.