Rectal CancerPhase 2NCT06210971
Neoadjuvant Chemoradiation With Nal-IRI and Capecitabine Guided by UGT1A1 Status in Patients With Rectal Cancer
A Phase 2 study testing liposomal irinotecan, Capecitabine and Radiation threapy in people with Rectal Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
This single-arm trial will explore the efficacy and safety of long-course neoadjuvant chemoradiation with liposomal irinotecan and capecitabine guided by UGT1A1 status in patients with locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- liposomal irinotecan, Capecitabine and Radiation threapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 1 Jul 2028
- 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
- Age: 18~75 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0~1.
- Histopathologically confirmed rectal adenocarcinoma.
- The lower edge of the primary tumor is located below the peritoneal reflection or located ≤ 10 cm above the anal verge.
- Clinical stage: T3-4NanyM0 or T1-2N+M0.
- Adequate bone marrow function as evidenced by: Absolute neutrophil count (ANC) ≥1.5×10^9/L, Platelet count ≥100×10^9/L, Hemoglobin (Hb) ≥90 g/L.
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- Adequate hepatic function as evidenced by: Total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN, Serum albumin ≥3 g/dL.
- Adequate renal function as evidenced by: Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance ≥60 mL/min.
- Be willing to undergo UGT1A1 gene testing and UGT1A1 genotype of *1*1 or *1*28.
- Accept the neoadjuvant chemoradiotherapy protocol of this study and sign the informed consent.
Who cannot join
- Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc.
- Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
- Active HIV infection.
- Combined with uncontrollable systemic diseases.
- History of allergy or hypersensitivity to drug or any of their excipients.
- Any clinical indicators indicating contraindications to radiotherapy/chemotherapy and surgery.
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- Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1.
- Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception.
- Patients with poor cognitive abilities who are unable to answer questions, fill out questionnaires, or have mental disorders.
- Patients who do not meet the inclusion criteria; patients who meet the inclusion criteria but are not suitable to participate in this trial judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, 050000
About this study
Official title: Exploratory Study on the Efficacy and Safety of Long-course Neoadjuvant Chemoradiation With Liposomal Irinotecan and Capecitabine Guided by UGT1A1 Status in Patients With Locally Advanced Rectal Cancer
This single-arm trial will explore the efficacy and safety of long-course neoadjuvant chemoradiation with liposomal irinotecan and capecitabine guided by UGT1A1 status in patients with locally advanced rectal cancer.
Read the detailed description
This is a single-center, single-arm, prospective clinical study. The aim of this study is to explore the short-term and long-term efficacy and safety of total neoadjuvant therapy with irinotecan liposome in patients with locally advanced rectal cancer. Patients' nutritional status, quality of life, changes in symptoms, and adverse events will also be regularly assessed and registered during the implementation phase of the study, and patients will be treated promptly if symptoms are assessed as positive.
- Conditions
- Rectal Cancer
- Being tested
- liposomal irinotecan, Capecitabine, Radiation threapy
- Keywords
- UGT1A1, liposomal irinotecan, total neoadjuvant therapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal irinotecanDrug
Also called nal-IRI
Liposomal irinotecan: 50mg/m^2 or 70mg/m^2
CapecitabineDrug
Also called Xeloda
Capecitabine: 625mg/m^2 or 1000mg/m^2 bid.
Radiation threapyRadiation
Also called RT
50.4Gy/28 fractions
| Study group | Role | What they receive |
|---|---|---|
| Liposomal irinotecan-based TNT therapy | Experimental | Concurrent Chemoradiotherapy (Radiation 50.4Gy/28 fractions + Capecitabine 625mg/m^2 bid + Liposomal irinotecan 50mg/m^2) followed by 4-6 cycles of Chemotherapy (Capecitabine 1000mg/m^2 bid d1-7 + Liposomal irinotecan 70mg/m^2 or 50mg/m^2, d1, Q2W) before surgery. Receives: Drug: liposomal irinotecan; Drug: Capecitabine; Radiation: Radiation threapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response
Defined as the proportion of patients who have achieved pathologic complete response.
Measured: 1 week after sugery
Secondary outcomes (9)
clinical complete response
Defined as the proportion of patients who have achieved clinical complete response.
Measured: up to 30 weeks
Major Pathologic Response
Defined as the proportion of patients who have achieved major pathologic response
Measured: 1 week after sugery
Objective Response Rate
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
Measured: through study completion，an average of 3 year
Anal Sphincter Retention Rate
Defined as the proportion of patients who retain anal sphincter
Measured: 1 week after sugery
R0 resection rate
Defined as the proportion of patients who have achieved R0 resection.
Measured: 1 week after sugery
3-year Local Recurrence Free Survival Rate
Defined as the proportion of patients who are not local recurrence or death at 3 years after enrollment.
Measured: 3 years
3-year Progress Free Survival Rate
Defined as the proportion of patients who are not progress or death at 3 years after enrollment.
Measured: 3 years
3-year Overall Survival Rate
Defined as the proportion of patients who are alive at 3 years after enrollment.
Measured: 3 years
Incidence of adverse events
Use NCI-CTCAE version 5.0 for classification and grading.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Feb 2024
- Primary completion30 Sep 2025
- Study completion1 Jul 2028 (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.
- More trials run by Hebei Medical University Fourth 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fengpeng Wu, Professor, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210971
- Sponsor's protocol ID
- CSPC-DEY-CRC-K08
- Status last verified
- Mar 2026
- First submitted
- 7 Jan 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Efficacy and Safety of Long-course Neoadjuvant Chemoradiation With Liposomal Irinotecan and Capecitabine Guided by UGT1A1 Status in Patients With Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT06210971
- Acronym / sponsor ID
- CSPC-DEY-CRC-K08
- Conditions
- Rectal Cancer
- Keywords
- UGT1A1, liposomal irinotecan, total neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 18 Jan 2024 (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 single-arm trial will explore the efficacy and safety of long-course neoadjuvant chemoradiation with liposomal irinotecan and capecitabine guided by UGT1A1 status in patients with locally advanced rectal cancer.
Detailed description
This is a single-center, single-arm, prospective clinical study. The aim of this study is to explore the short-term and long-term efficacy and safety of total neoadjuvant therapy with irinotecan liposome in patients with locally advanced rectal cancer. Patients' nutritional status, quality of life, changes in symptoms, and adverse events will also be regularly assessed and registered during the implementation phase of the study, and patients will be treated promptly if symptoms are assessed as positive.
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-based TNT therapy | Experimental | Drug: liposomal irinotecan, Drug: Capecitabine, Radiation: Radiation threapyConcurrent Chemoradiotherapy (Radiation 50.4Gy/28 fractions + Capecitabine 625mg/m^2 bid + Liposomal irinotecan 50mg/m^2) followed by 4-6 cycles of Chemotherapy (Capecitabine 1000mg/m^2 bid d1-7 + Liposomal irinotecan 70mg/m^2 or 50mg/m^2, d1, Q2W) before surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18~75 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0~1.
- Histopathologically confirmed rectal adenocarcinoma.
- The lower edge of the primary tumor is located below the peritoneal reflection or located ≤ 10 cm above the anal verge.
- Clinical stage: T3-4NanyM0 or T1-2N+M0.
Key exclusion criteria (10 listed)
- Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc.
- Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
- Active HIV infection.
- Combined with uncontrollable systemic diseases.
- History of allergy or hypersensitivity to drug or any of their excipients.
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 |
|---|---|---|
| liposomal irinotecanAlso: nal-IRILiposomal irinotecan: 50mg/m^2 or 70mg/m^2 | Drug | Liposomal irinotecan-based TNT therapy |
| CapecitabineAlso: XelodaCapecitabine: 625mg/m^2 or 1000mg/m^2 bid. | Drug | Liposomal irinotecan-based TNT therapy |
| Radiation threapyAlso: RT50.4Gy/28 fractions | Radiation | Liposomal irinotecan-based TNT therapy |
Primary outcome
Pathologic Complete Response
Time frame: 1 week after sugery
Defined as the proportion of patients who have achieved pathologic complete response.
9 secondary outcomes
clinical complete response
Time frame: up to 30 weeks
Major Pathologic Response
Time frame: 1 week after sugery
Objective Response Rate
Time frame: through study completion，an average of 3 year
Anal Sphincter Retention Rate
Time frame: 1 week after sugery
R0 resection rate
Time frame: 1 week after sugery
3-year Local Recurrence Free Survival Rate
Time frame: 3 years
3-year Progress Free Survival Rate
Time frame: 3 years
3-year Overall Survival Rate
Time frame: 3 years
Incidence of adverse events
Time frame: 7 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 3 Aug 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. This study is not recruiting at the moment.
Fengpeng Wu, Professor principal investigator
Hebei Medical University Fourth Hospital
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 liposomal irinotecan, Capecitabine and Radiation threapy in people with Rectal Cancer, run by Hebei Medical University Fourth 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 10 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 3 Aug 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (time frame: 1 week after sugery). 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 Aug 2026.