Colorectal NeoplasmsPhase 3NCT03303495
A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC
A Phase 3 study testing Bevacizumab, CPT-11 and 5-FU Bolus in people with Colorectal Neoplasms and Neoplasm Metastasis, run by Sun Yat-sen University at 1 site in China.
Trial summary
The primary purpose of this study is to determine the non-inferiority of overall survival FOLFIRI with or without Bevacizumab compared with Irinotecan (CPT-11) with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Neoplasm Metastasis, Intestinal Neoplasms
- What is being tested?
- Bevacizumab, CPT-11 and 5-FU Bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2011to 31 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer.
- Age ≥18 years at the time of informed consent
- ECOG performance status (PS) of 0-2
- Written informed consent prior to study-specific screening procedures
- Life expectancy of at least 90 days
- Withdrawal from first-line chemotherapy (regardless of containing molecular-targeted drugs) for metastatic colorectal cancer due to intolerable toxicity or progressive disease, or relapse within 180 days after the last dose of adjuvant chemotherapy.
- Adequate organ function according to following laboratory values obtained within 14 days before enrolment (excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test) Neutrophil count: ≥1500/mm3 Platelet count: ≥10.0 x 104/mm3 Hemoglobin: ≥9.0 g/dL Total bilirubin: ≤1.5 mg/dL AST, ALT: ≤100 IU/L (≤200 IU/I if liver metastases present) Serum creatinine: ≤1.5 mg/dL
Who cannot join
- History of other malignancy with a disease-free interval <5 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated carcinoma in situ of the cervix, and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection)
- With massive pleural effusion or ascites requiring intervention
- Radiological evidence of brain tumor or brain metastases
- Active infection including hepatitis
- Any of the following complication:
- Gastrointestinal bleeding or gastrointestinal obstruction (including paralytic ileus) ii) Symptomatic heart disease (including unstable angina, myocardial infarction, and heart failure) iii) Interstitial pneumonia or pulmonary fibrosis iv) Uncontrolled diabetes mellitus v) Uncontrolled diarrhea (that interferes with daily activities despite adequate therapy)
Show all 24Show fewer
- Any of the following medical history:
- Myocardial infarction: History of one episode within one year before enrollment or two or more lifetime episodes i) Serious hypersensitivity to any of the study drugs ii) History of adverse reaction to fluoropyrimidines suggesting dihydropyrimidine dehydrogenase (DPD) deficiency
- Previous treatment with irinotecan hydrochloride
- Current treatment with atazanavir sulfate
- Previous treatment with tegafur, gimeracil, and oteracil potassium within seven days before enrollment
- Pregnant or lactating females, and males and females unwilling to use contraception
- Requires continuous treatment with systemic steroids
- Psychiatric disability that would preclude study compliance
- Otherwise determined by the investigator to be unsuitable for participation in the study
- Concurrent gastrointestinal perforation or history of gastrointestinal perforation with 1 year before enrollment
- History of pulmonary hemorrhage/hemoptysis ≥ Grade 2 (defined as bright red blood of at least 2.5mL) within 1 month prior to enrollment.
- History of laparotomy, thoracotomy, or intestinal resection within 28 days before enrollment
- Unhealed wound (except suture wounds from implantation of a central venous port), gastrointestinal ulcer, or traumatic fracture
- Current or recent (within 1 year) thromboembolism or cerebrovascular disease
- Currently receiving or requires anticoagulation therapy (> 325 mg/day of aspirin)
- Bleeding diathesis, coagulopathy, or coagulation factor abnormality (INR ≥1.5 within 14 days before enrollment)
- Uncontrolled hypertension
- Urine dipstick for proteinuria >+2
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
Cancer center of Sun Yat-sen University
Guangzhou, Guangdong, 510060
Rui-Hua Xu, MD, PhD, 86-020-87343333, xurh@sysucc.org.cn
De-shen Wang, MD, PhD, 86-020-87343351, wangdsh@sysucc.org.cn
About this study
Official title: A Multinational, Randomized, Phase III Study of FOLFIRI With/Without Bevacizumab Versus Irinotecan With/Without Bevacizumab As Second-line Therapy in Patients With Metastatic Colorectal Cancer
The primary purpose of this study is to determine the non-inferiority of overall survival FOLFIRI with or without Bevacizumab compared with Irinotecan (CPT-11) with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.
Read the detailed description
Primary endpoint: Progression-free survival (PFS)； Secondary endpoints: Overall survival (OS), Time to treatment failure (TTF), Overall response rate (ORR), Disease Control Rate (DCR), Safety.
- Conditions
- Colorectal Neoplasms, Neoplasm Metastasis, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms
- Being tested
- Bevacizumab, CPT-11, 5-FU Bolus, 5-FU Infusion, l-LV (dl-LV)
- Keywords
- FOLFIRI, CPT-11, Bevacizumab, 2nd-line metastatic colorectal cancer
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabBiological
Also called Avastin
5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle.
CPT-11Drug
Also called Irinotecan
180 mg/m2 intravenously administered over 90 minutes on day 1 of a 2-week cycle
5-FU BolusDrug
Also called fluorouracil
400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.
5-FU InfusionDrug
Also called fluorouracil
2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.
l-LV (dl-LV)Drug
Also called Leucovorin
200 (dl-LV: 400) mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRI +/- Bevacizumab | Experimental | Bevacizumab 5 mg/kg IV 90-30 min Day 1; CPT-11 180 mg/m2 IV 90 min Day 1; l-LV (dl-LV) 200 mg/m2 (400 mg/m2) IV 120 min Day 1; 5-FU - bolus 400 mg/m2 IV bolus Day 1; 5-FU - infusional 2400 mg/m2 IV continuous (46 hours) Day 1 - 3 Receives: Biological: Bevacizumab; Drug: CPT-11; Drug: 5-FU Bolus; Drug: 5-FU Infusion; Drug: l-LV (dl-LV) |
| CPT-11 +/- Bevacizumab | Experimental | Bevacizumab 5 mg/kg IV 90-30 min Day 1; CPT-11 180 mg/m2 IV 90 min Day 1 Receives: Biological: Bevacizumab; Drug: CPT-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Time from the date of enrollment to the earlier of the date of confirmed progression or death from any cause.
Measured: Assessed until 1.5 years after the last patient enrolment
Secondary outcomes (5)
Overall survival
Time from the date of enrollment to death from any cause
Measured: Assessed until 1.5 years after the last patient enrolment
Time to treatment failure (TTF)
Time from the date of enrollment to the earlier of the date of confirmed progression, death from any cause, or discontinuation of protocol treatment.
Measured: Assessed until 1.5 years after the last patient enrolment
Overall Response Rate (ORR)
Proportion of eligible patients with measurable lesions with a best overall response of CR or PR assessed by the attending physician.
Measured: Assessed at 6, 12 week and thereafter every 8 weeks, from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks
Disease Control Rate (DCR)
Proportion of best overall response of CR, PR, or SD assessed by the attending physician.
Measured: Assessed at 6, 12 week and thereafter every 8 weeks, from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks
Incidence of Adverse Events (Adverse Reactions)
The incidence of worst-grade adverse events (toxicities) on study as graded by NCI-CTCAE v 4.0 will be determined by treatment arm in all treated patients for the following events.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start14 Nov 2011
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui-hua Xu, MD, PhD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303495
- Sponsor's protocol ID
- RECHANGE
- Status last verified
- Jun 2026
- First submitted
- 23 Sep 2017
- Last updated
- 5 Jun 2026
- Results posted
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Randomized, Phase III Study of FOLFIRI With/Without Bevacizumab Versus Irinotecan With/Without Bevacizumab As Second-line Therapy in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03303495
- Acronym / sponsor ID
- RECHANGE
- Conditions
- Colorectal Neoplasms, Neoplasm Metastasis, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms
- Keywords
- FOLFIRI, CPT-11, Bevacizumab, 2nd-line metastatic colorectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 14 Nov 2011 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Oct 2017 (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.
The primary purpose of this study is to determine the non-inferiority of overall survival FOLFIRI with or without Bevacizumab compared with Irinotecan (CPT-11) with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.
Detailed description
Primary endpoint: Progression-free survival (PFS)； Secondary endpoints: Overall survival (OS), Time to treatment failure (TTF), Overall response rate (ORR), Disease Control Rate (DCR), Safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFIRI +/- Bevacizumab | Experimental | Biological: Bevacizumab, Drug: CPT-11, Drug: 5-FU Bolus, Drug: 5-FU Infusion, Drug: l-LV (dl-LV)Bevacizumab 5 mg/kg IV 90-30 min Day 1; CPT-11 180 mg/m2 IV 90 min Day 1; l-LV (dl-LV) 200 mg/m2 (400 mg/m2) IV 120 min Day 1; 5-FU - bolus 400 mg/m2 IV bolus Day 1; 5-FU - infusional 2400 mg/m2 IV continuous (46 hours) Day 1 - 3 |
| CPT-11 +/- Bevacizumab | Experimental | Biological: Bevacizumab, Drug: CPT-11Bevacizumab 5 mg/kg IV 90-30 min Day 1; CPT-11 180 mg/m2 IV 90 min Day 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer.
- Age ≥18 years at the time of informed consent
- ECOG performance status (PS) of 0-2
- Written informed consent prior to study-specific screening procedures
- Life expectancy of at least 90 days
Key exclusion criteria (24 listed)
- History of other malignancy with a disease-free interval <5 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated carcinoma in situ of the cervix, and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection)
- With massive pleural effusion or ascites requiring intervention
- Radiological evidence of brain tumor or brain metastases
- Active infection including hepatitis
- Any of the following complication:
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 |
|---|---|---|
| BevacizumabAlso: Avastin5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle. | Biological | CPT-11 +/- Bevacizumab, FOLFIRI +/- Bevacizumab |
| CPT-11Also: Irinotecan180 mg/m2 intravenously administered over 90 minutes on day 1 of a 2-week cycle | Drug | CPT-11 +/- Bevacizumab, FOLFIRI +/- Bevacizumab |
| 5-FU BolusAlso: fluorouracil400 mg/m2 intravenous bolus on day 1 of a 2-week cycle. | Drug | FOLFIRI +/- Bevacizumab |
| 5-FU InfusionAlso: fluorouracil2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle. | Drug | FOLFIRI +/- Bevacizumab |
| l-LV (dl-LV)Also: Leucovorin200 (dl-LV: 400) mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. | Drug | FOLFIRI +/- Bevacizumab |
Primary outcome
Progression-free survival (PFS)
Time frame: Assessed until 1.5 years after the last patient enrolment
Time from the date of enrollment to the earlier of the date of confirmed progression or death from any cause.
5 secondary outcomes
Overall survival
Time frame: Assessed until 1.5 years after the last patient enrolment
Time to treatment failure (TTF)
Time frame: Assessed until 1.5 years after the last patient enrolment
Overall Response Rate (ORR)
Time frame: Assessed at 6, 12 week and thereafter every 8 weeks, from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks
Disease Control Rate (DCR)
Time frame: Assessed at 6, 12 week and thereafter every 8 weeks, from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks
Incidence of Adverse Events (Adverse Reactions)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks
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 5 Jun 2026.
- Individual participant dataSharing planned: Yes
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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 Bevacizumab, CPT-11 and 5-FU Bolus in people with Colorectal Neoplasms and Neoplasm Metastasis, run by Sun Yat-sen University 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 7 inclusion and 24 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 5 Jun 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 Ruihua Xu, MD, PhD (87343333, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Assessed until 1.5 years after the last patient enrolment). 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 5 Jun 2026.