Locally Advanced Rectal CancerPhase 3CinClare-2NCT07074353
Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer
A Phase 3 study testing NALIRI, LCRT and FOLFOX in people with Locally Advanced Rectal Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This study enrolled patients with locally advanced rectal cancer. The experimental group received irinotecan liposomes combined with standard total neoadjuvant therapy (TNT), while the control group received standard TNT. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- NALIRI, LCRT and FOLFOX
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2025to 1 Jul 2030
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 75 years, both male and female are eligible;
- Histologically confirmed rectal adenocarcinoma;
- Clinical stage assessed by MRI as T3-4 or N+ (according to the 8th edition of the AJCC);
- Distance from the lower edge of the tumor to the anal verge ≤ 10 cm;
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-1;
- UGT1A1*6 and UGT1A1*28 gene phenotypes are either wild-type (GG+6/6) or single-site mutant (GG+6/7 or GA+6/6);
- No prior anti-tumor treatment for rectal cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.;
- Normal function of major organs.
Who cannot join
- Previous or ongoing treatment for rectal cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
- Known MSI-H (high microsatellite instability) by genetic testing or dMMR (deficient mismatch repair) by immunohistochemistry.
- Known hypersensitivity, allergic reaction, or contraindication to irinotecan liposomes/vehicle, irinotecan, other liposomal products, 5-FU, leucovorin, oxaliplatin, or any of these agents.
- Uncontrolled cardiac symptoms or disease.
- Severe infection (CTCAE > Grade 2) within 4 weeks prior to the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications; baseline chest imaging showing active pulmonary inflammation; signs and symptoms of infection within 14 days prior to the first use of the study drug or requiring oral or intravenous antibiotic therapy, excluding prophylactic use of antibiotics.
- Severe gastrointestinal dysfunction (inflammation or diarrhea greater than Grade 1).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Multicenter Clinical Study of Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer
This study enrolled patients with locally advanced rectal cancer. The experimental group received irinotecan liposomes combined with standard total neoadjuvant therapy (TNT), while the control group received standard TNT. The study endpoints were the complete response rate (cCR + pCR), 3-year event-free survival (EFS) rate, and overall survival (OS). The aim was to compare the efficacy and safety of irinotecan liposomes combined with or without standard TNT.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- NALIRI, LCRT, FOLFOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NALIRIDrug
Irinotecan liposomes
LCRTRadiation
Long-course concurrent chemoradiotherapy
FOLFOXDrug
Fluorouracil/Leucovorin, Oxaliplatin (5-FU/LV, OX)
| Study group | Role | What they receive |
|---|---|---|
| NALIRI-TNT | Experimental | Irinotecan Liposomes+Long-course concurrent chemoradiotherapy followed by consolidation chemotherapy Receives: Drug: NALIRI; Radiation: LCRT; Drug: FOLFOX |
| TNT | Placebo comparator | Long-course concurrent chemoradiotherapy followed by consolidation chemotherapy Receives: Radiation: LCRT; Drug: FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response rate（CR）
Clinical Complete Response rate（cCR）+ Pathological Complete Response rate （pCR）
Measured: cCR: before the surgery, and up to 4 weeks after the end of completation of total neoadjuvant therapy (TNT) for cCR. pCR: after the surgery.
Secondary outcomes (1)
3-year event-free survival (3y-EFS)
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 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start20 Jul 2025 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Zhu, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074353
- Sponsor's protocol ID
- CinClare-2
- Acronym
- CinClare-2
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 25 Jul 2025
- 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 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter Clinical Study of Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT07074353
- Acronym / sponsor ID
- CinClare-2 / CinClare-2
- Conditions
- Locally Advanced Rectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 20 Jul 2025 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 20 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 study enrolled patients with locally advanced rectal cancer. The experimental group received irinotecan liposomes combined with standard total neoadjuvant therapy (TNT), while the control group received standard TNT. The study endpoints were the complete response rate (cCR + pCR), 3-year event-free survival (EFS) rate, and overall survival (OS). The aim was to compare the efficacy and safety of irinotecan liposomes combined with or without standard TNT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NALIRI-TNT | Experimental | Drug: NALIRI, Radiation: LCRT, Drug: FOLFOXIrinotecan Liposomes+Long-course concurrent chemoradiotherapy followed by consolidation chemotherapy |
| TNT | Placebo comparator | Radiation: LCRT, Drug: FOLFOXLong-course concurrent chemoradiotherapy followed by consolidation chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years and ≤ 75 years, both male and female are eligible;
- Histologically confirmed rectal adenocarcinoma;
- Clinical stage assessed by MRI as T3-4 or N+ (according to the 8th edition of the AJCC);
- Distance from the lower edge of the tumor to the anal verge ≤ 10 cm;
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-1;
Key exclusion criteria (6 listed)
- Previous or ongoing treatment for rectal cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
- Known MSI-H (high microsatellite instability) by genetic testing or dMMR (deficient mismatch repair) by immunohistochemistry.
- Known hypersensitivity, allergic reaction, or contraindication to irinotecan liposomes/vehicle, irinotecan, other liposomal products, 5-FU, leucovorin, oxaliplatin, or any of these agents.
- Uncontrolled cardiac symptoms or disease.
- Severe infection (CTCAE > Grade 2) within 4 weeks prior to the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications; baseline chest imaging showing active pulmonary inflammation; signs and symptoms of infection within 14 days prior to the first use of the study drug or requiring oral or intravenous antibiotic therapy, excluding prophylactic use of antibiotics.
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 |
|---|---|---|
| NALIRIIrinotecan liposomes | Drug | NALIRI-TNT |
| LCRTLong-course concurrent chemoradiotherapy | Radiation | NALIRI-TNT, TNT |
| FOLFOXFluorouracil/Leucovorin, Oxaliplatin (5-FU/LV, OX) | Drug | NALIRI-TNT, TNT |
Primary outcome
Complete Response rate（CR）
Time frame: cCR: before the surgery, and up to 4 weeks after the end of completation of total neoadjuvant therapy (TNT) for cCR. pCR: after the surgery.
Clinical Complete Response rate（cCR）+ Pathological Complete Response rate （pCR）
1 secondary outcome
3-year event-free survival (3y-EFS)
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 100 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 25 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 3 study testing NALIRI, LCRT and FOLFOX in people with Locally Advanced Rectal Cancer, run by Zhejiang Cancer 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 8 inclusion and 6 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 25 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. Some participants in this study may receive a placebo. 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 Ji ZHU (0571-88128212, zhuji@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response rate（CR） (time frame: cCR: before the surgery, and up to 4 weeks after the end of completation of total neoadjuvant therapy (TNT) for cCR. pCR: after the surgery.). 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 25 Jul 2025.