Colorectal Cancer (CRC)Phase 2NCT07047560
Liposomal Irinotecan (II) Fractionated Dosing Combined With 5-FU/LV (FOLFIRInali-3) and Bevacizumab in Second-line Treatment of Advanced Colorectal Cancer: A Single-arm, Phase II Clinical Study
A Phase 2 study testing fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev) in people with Colorectal Cancer (CRC), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is an investigator-initiated, prospective, multicenter, single-arm phase II clinical study. It aims to evaluate the efficacy and safety of fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev) as second-line treatment for advanced colorectal cancer, with the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer (CRC)
- What is being tested?
- fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 Aug 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed the informed consent；
- Male or female patients ≥18 years old;
- ECOG physical status score is 0 or 1;
- Patients with pathologically confirmed advanced colorectal carcinoma (all other histological types excluded);
- Patients who experienced disease progression under either of the following circumstances:During or within 6 months after first-line oxaliplatin-containing chemotherapy, or within 1 year after completing oxaliplatin-based adjuvant chemotherapy post-resection;
- Expected survival time ≥ 3 months;
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- Patients must have at least one measurable metastatic lesion according to RECIST version 1.1;
- Normal organ function:
- Hematology :Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1500/mm3); Platelet count ≥ 100 × 109/L (100000/mm3); Hemoglobin ≥ 90g/L;
- Kidney:The calculated value of creatinine clearance rate (CrCl) is ≥ 50 mL/min; Normal urine routine, urine protein<2+or 24-hour (h) urine protein quantification<1.0 g;
- Liver:Total serum bilirubin (TBiL) ≤ 1.5 × ULN;AST and ALT ≤ 2.5 × ULN; For subjects with liver metastasis, AST and ALT can be ≤ 5 × ULN;Serum albumin (ALB) ≥ 30g/L;
- Normal coagulation function, international standardized ratio (INR) ≤ 1.5 x ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN;
- Women of childbearing age must undergo a pregnancy test (serum or urine) with a negative result within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug; For males, surgical sterilization or agreement to use appropriate methods of contraception during observation and within 8 weeks after the last administration of study medication should be considered;
- Comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study;
Who cannot join
- History of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ);
- Participation in other drug trials within 4 weeks prior to enrollment;
- Uncontrolled hypertension (SBP >160 mmHg or DBP >100 mmHg);
- Acute coronary syndrome (including MI/unstable angina) with coronary angioplasty/stent placement within 6 months;
- NYHA class II+ heart failure, unstable angina, MI, or severe arrhythmia with cardiovascular impairment within 6 months;
- Symptomatic brain metastases;
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- Severe comorbidities requiring hospitalization (e.g., ileus, bowel obstruction, pulmonary fibrosis, refractory diabetes, heart/kidney/liver failure, psychiatric/cerebrovascular disorders);
- Gastrointestinal perforation/fistula, intra-abdominal abscess, or non-GI fistula within 6 months;
- Concomitant use of strong CYP3A4/CYP2C8 inhibitors/inducers or UGT1A1 inhibitors within 2 weeks;
- Pregnancy or lactation;
- Other investigator-determined contraindications.
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
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Ting Deng, MD, 022-23340123 ext. 1053, xymcdengting@126.com
Ting Deng, MD
About this study
This is an investigator-initiated, prospective, multicenter, single-arm phase II clinical study. It aims to evaluate the efficacy and safety of fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev) as second-line treatment for advanced colorectal cancer, with the primary endpoint being objective response rate (ORR).
Eligible subjects will receive second-line treatment with the FOLFIRInali-3 （Liposomal irinotecan (II) fractionated dosing combined with 5-FU/LV） plus bevacizumab (Bev) 。Treatment will be discontinued upon occurrence of any of the following: Disease progression (radiologically confirmed)，intolerable toxicity (unmanageable after dose modification)， initiation of new antitumor therapy, withdrawal of informed consent or investigator's discretion (based on clinical judgment). Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.
Read the detailed description
This is an investigator-initiated, prospective, multicenter, single-arm phase II clinical study. It aims to evaluate the efficacy and safety of fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev) as second-line treatment for advanced colorectal cancer, with the primary endpoint being objective response rate (ORR).
Prospective participants must undergo screening assessments within 28 days before randomization to determine eligibility. Eligible subjects will receive second-line treatment with the FOLFIRInali-3 plus bevacizumab (Bev) regimen as follows:
- Liposomal irinotecan (II): 30 mg/m² IV on D1 and D3
- Fluorouracil (5-FU):
- 400 mg/m² IV bolus on D1
- Followed by 2400 mg/m² continuous IV infusion over 46-48 hours
- Leucovorin (LV): 400 mg/m² IV infusion on D1
- Bevacizumab: 5 mg/kg IV infusion on D1。
Treatment will be discontinued upon occurrence of any of the following:
- Disease progression (radiologically confirmed)
- Intolerable toxicity (unmanageable after dose modification)
- Initiation of new antitumor therapy
- Withdrawal of informed consent
- Investigator's discretion (based on clinical judgment)
Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.
- Conditions
- Colorectal Cancer (CRC)
- Being tested
- fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev)
- Keywords
- Liposomal irinotecan, colorectal cancer, fractionated dosing
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev)Drug
Liposomal irinotecan (II): 30 mg/m² IV on D1 and D3, Q2W; Fluorouracil (5-FU): Q2W;
- 400 mg/m² IV bolus on D1
- Followed by 2400 mg/m² continuous IV infusion over 46-48 hours Leucovorin (LV): 400 mg/m² IV infusion on D1 Bevacizumab: 5 mg/kg IV infusion on D1, Q2W.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal irinotecan (II) fractionated dosing combined with 5-FU/LV and bevacizumab | Experimental | Liposomal irinotecan (II): 30 mg/m² IV on D1 and D3, Q2W Fluorouracil (5-FU): Q2W
* 400 mg/m² IV bolus on D1
* Followed by 2400 mg/m² continuous IV infusion over 46-48 hours Leucovorin (LV): 400 mg/m² IV infusion on D1 Bevacizumab: 5 mg/kg IV infusion on D1, Q2W Receives: Drug: fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate,ORR
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
Measured: 6 months
Secondary outcomes (2)
Overall survival,OS
Defined as the time between signing the informed consent form to death due to various causes.
Measured: 24 months
Incidence of adverse events
Use NCI-CTCAE version 5.0 for classification and grading.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Sep 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- 46 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047560
- Sponsor's protocol ID
- TJFOLFIRInali-3
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Irinotecan (II) Fractionated Dosing Combined With 5-FU/LV (FOLFIRInali-3) and Bevacizumab in Second-line Treatment of Advanced Colorectal Cancer: A Single-arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07047560
- Acronym / sponsor ID
- TJFOLFIRInali-3
- Conditions
- Colorectal Cancer (CRC)
- Keywords
- Liposomal irinotecan, colorectal cancer, fractionated dosing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 2 Jul 2025 (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.
This is an investigator-initiated, prospective, multicenter, single-arm phase II clinical study. It aims to evaluate the efficacy and safety of fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev) as second-line treatment for advanced colorectal cancer, with the primary endpoint being objective response rate (ORR).
Eligible subjects will receive second-line treatment with the FOLFIRInali-3 （Liposomal irinotecan (II) fractionated dosing combined with 5-FU/LV） plus bevacizumab (Bev) 。Treatment will be discontinued upon occurrence of any of the following: Disease progression (radiologically confirmed)，intolerable toxicity (unmanageable after dose modification)， initiation of new antitumor therapy, withdrawal of informed consent or investigator's discretion (based on clinical judgment). Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.
Detailed description
This is an investigator-initiated, prospective, multicenter, single-arm phase II clinical study. It aims to evaluate the efficacy and safety of fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev) as second-line treatment for advanced colorectal cancer, with the primary endpoint being objective response rate (ORR).
Prospective participants must undergo screening assessments within 28 days before randomization to determine eligibility. Eligible subjects will receive second-line treatment with the FOLFIRInali-3 plus bevacizumab (Bev) regimen as follows:
- Liposomal irinotecan (II): 30 mg/m² IV on D1 and D3
- Fluorouracil (5-FU):
- 400 mg/m² IV bolus on D1
- Followed by 2400 mg/m² continuous IV infusion over 46-48 hours
- Leucovorin (LV): 400 mg/m² IV infusion on D1
- Bevacizumab: 5 mg/kg IV infusion on D1。
Treatment will be discontinued upon occurrence of any of the following:
- Disease progression (radiologically confirmed)
- Intolerable toxicity (unmanageable after dose modification)
- Initiation of new antitumor therapy
- Withdrawal of informed consent
- Investigator's discretion (based on clinical judgment)
Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liposomal irinotecan (II) fractionated dosing combined with 5-FU/LV and bevacizumab | Experimental | Drug: fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev)Liposomal irinotecan (II): 30 mg/m² IV on D1 and D3, Q2W Fluorouracil (5-FU): Q2W * 400 mg/m² IV bolus on D1 * Followed by 2400 mg/m² continuous IV infusion over 46-48 hours Leucovorin (LV): 400 mg/m² IV infusion on D1 Bevacizumab: 5 mg/kg IV infusion on D1, Q2W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed the informed consent；
- Male or female patients ≥18 years old;
- ECOG physical status score is 0 or 1;
- Patients with pathologically confirmed advanced colorectal carcinoma (all other histological types excluded);
- Patients who experienced disease progression under either of the following circumstances:During or within 6 months after first-line oxaliplatin-containing chemotherapy, or within 1 year after completing oxaliplatin-based adjuvant chemotherapy post-resection;
Key exclusion criteria (11 listed)
- History of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ);
- Participation in other drug trials within 4 weeks prior to enrollment;
- Uncontrolled hypertension (SBP >160 mmHg or DBP >100 mmHg);
- Acute coronary syndrome (including MI/unstable angina) with coronary angioplasty/stent placement within 6 months;
- NYHA class II+ heart failure, unstable angina, MI, or severe arrhythmia with cardiovascular impairment within 6 months;
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 |
|---|---|---|
| fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev)Liposomal irinotecan (II): 30 mg/m² IV on D1 and D3, Q2W; Fluorouracil (5-FU): Q2W; * 400 mg/m² IV bolus on D1 * Followed by 2400 mg/m² continuous IV infusion over 46-48 hours Leucovorin (LV): 400 mg/m² IV infusion on D1 Bevacizumab: 5 mg/kg IV infusion on D1, Q2W. | Drug | Liposomal irinotecan (II) fractionated dosing combined with 5-FU/LV and bevacizumab |
Primary outcome
Objective Response Rate,ORR
Time frame: 6 months
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
2 secondary outcomes
Overall survival,OS
Time frame: 24 months
Incidence of adverse events
Time frame: 24 months
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 2 Jul 2025.
- 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 2 study testing fractionated liposomal irinotecan (II)-based combination chemotherapy (FOLFIRInali-3) plus bevacizumab (Bev) in people with Colorectal Cancer (CRC), run by Tianjin Medical University Cancer Institute and Hospital 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 14 inclusion and 11 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 2 Jul 2025. 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 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 Ting Deng, MD (022-23340123 ext. 1053, xymcdengting@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate,ORR (time frame: 6 months). 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 2 Jul 2025.