Rectal Cancer, AdenocarcinomaNCT07474103
SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARC
A study testing SCRT, Liposomal Irinotecan and Oxaliplatin in people with Rectal Cancer, Adenocarcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This is a single-center, exploratory clinical study for patients with newly diagnosed, high-risk, locally advanced rectal cancer. The study aims to evaluate the effectiveness and safety of a comprehensive pre-surgery (neoadjuvant) treatment strategy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Adenocarcinoma
- What is being tested?
- SCRT, Liposomal Irinotecan and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2025to 31 Dec 2028
- Phase
- Interventional
- 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
- Voluntary Participation: Subjects voluntarily participate in the study, sign the informed consent form, and have good compliance.
- Age and Gender: Age between 18 and 75 years, any gender.
- Pathological Diagnosis: Histologically or cytologically confirmed rectal adenocarcinoma; confirmed mismatch repair proficient (pMMR) or microsatellite stable (MSS) by genetic testing or immunohistochemistry.
- Disease Stage: Assessed as high-risk, mid-low (distance from the anal verge ≤10 cm) locally advanced rectal cancer by colonoscopy, digital rectal exam, or MRI. High-risk definition: Meeting at least one of the following: cT4, extramural vascular invasion (EMVI), tumor deposits, involvement of the mesorectal fascia or intersphincteric plane.
- Prior Treatment: No prior anti-tumor therapy for this rectal cancer (including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy).
- Measurable Lesion: At least one measurable lesion according to RECIST v1.1 criteria.
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- Tumor Tissue Sample: Must provide tumor tissue samples for biomarker analysis.
- Adequate Organ Function (within 7 days before the first dose): 1) Hematological: Hemoglobin ≥90 g/L; White Blood Cell count ≥3.0 x 10⁹/L; Absolute Neutrophil Count ≥1.5 x 10⁹/L; Platelets ≥100 x 10⁹/L. 2) Hepatic: Total Bilirubin <1.5 x ULN; AST and ALT ≤2.5 x ULN; Albumin ≥30 g/L. 3) Renal: Serum Creatinine ≤1.5 x ULN OR Creatinine Clearance ≥50 mL/min. 4) Coagulation: INR ≤1.5 x ULN (or ≤3 x ULN if on stable anticoagulant therapy); PTT or aPTT ≤1.5 x ULN (or ≤3 x ULN if on stable anticoagulant therapy).
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life Expectancy: Expected survival time ≥3 months.
- Good organ function.
- Contraception: Subjects of childbearing potential must agree to use effective contraception during the treatment period and for 6 months after the last dose.
Who cannot join
- Other Malignancies: Diagnosis of another malignancy within 5 years prior to the first dose, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ, localized prostate cancer, or papillary thyroid cancer, etc.
- Allergy: Known or suspected allergy to the study drugs or any of their excipients.
- Pregnancy and Lactation: Pregnant or lactating women, or women planning to become pregnant during the study or within 6 months after the last dose.
- Central Nervous System Disease: Known active epilepsy, active central nervous system (CNS) metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
- Significant Cardiovascular Disease: Clinically significant uncontrolled cardiovascular disease.
- History of Allergic Disease: History of allergic diathesis, asthma, or atopic dermatitis.
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- Pleural Effusion/Ascites: Presence of significant pleural effusion or ascites.
- Active Autoimmune Disease: Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose (replacement therapy is allowed).
- Immunosuppressant Use: Use of systemic corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressants within 2 weeks prior to enrollment.
- Interstitial Lung Disease: History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active pneumonia on screening chest CT scan.
- Transplantation History: History of allogeneic organ transplantation or hematopoietic stem cell transplantation.
- Active Infection: Positive HIV test result; Active Hepatitis B (HBV DNA ≥10⁴ copies/mL); Active Hepatitis C (HCV RNA ≥10³ copies/mL); Active Tuberculosis.
- Gastrointestinal Risk: History of bowel obstruction within 28 days prior to the first study dose; High risk of gastrointestinal perforation.
- Recent Major Surgery: Major surgical procedure within 4 weeks prior to enrollment.
- Other Exclusionary Conditions: Any other acute or chronic disease, mental disorder, or laboratory abnormality that, in the investigator's judgment, may increase the risk associated with study participation or drug administration, or interfere with the interpretation of study results.
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: Short-Course Radiotherapy Followed by Liposomal Irinotecan, Oxaliplatin, Capecitabine, and Sintilimab as Total Neoadjuvant Therapy in High-Risk Locally Advanced Rectal Cancer: A Single-Arm, Single-Center, Exploratory Study
This is a single-center, exploratory clinical study for patients with newly diagnosed, high-risk, locally advanced rectal cancer. The study aims to evaluate the effectiveness and safety of a comprehensive pre-surgery (neoadjuvant) treatment strategy.
All participants will receive a short course of radiation therapy (25 Gy in 5 fractions) over one week. This will be followed by a combination of chemotherapy (Liposomal Irinotecan, Oxaliplatin, and Capecitabine) and immunotherapy (Sintilimab). This combined treatment is administered for six cycles.
For patients who achieve a complete response, the option to avoid immediate surgery and enter a close monitoring program ("Watch and Wait") will be considered.
- Conditions
- Rectal Cancer, Adenocarcinoma
- Being tested
- SCRT, Liposomal Irinotecan, Oxaliplatin, Capecitabine, Sintilimab
- Keywords
- total neoadjuvant therapy, Short-Course Radiotherapy, Liposomal Irinotecan, rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCRTRadiation
Also called Short-Course Radiotherapy
25 Gy / 5 F
Liposomal IrinotecanDrug
Also called Nal-IRI, irinotecan liposome
50 mg/m², intravenously (IV) on Day 1 of each cycle.
OxaliplatinDrug
Also called OX
85 mg/m², IV on Day 1 of each cycle.
CapecitabineDrug
Also called Xeloda
800 mg/m², orally twice daily from Day 1 to Day 14 of each cycle.
SintilimabDrug
Also called IBI308
200 mg, IV on Day 1 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| SCRT followed by NALIRIXELOX + Sintilimab | Experimental | 1. Short-Course Radiotherapy (SCRT)
2. Systemic Therapy (Chemotherapy + Immunotherapy): Liposomal Irinotecan+Oxaliplatin+Capecitabine+Sintilimab Receives: Radiation: SCRT; Drug: Liposomal Irinotecan; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
The proportion of participants achieving either a Pathologic Complete Response (pCR) or a Clinical Complete Response (cCR). pCR is defined as the absence of viable tumor cells in the primary tumor and lymph nodes (ypT0N0) upon pathological examination after surgery. cCR is defined as the absence of residual tumor as confirmed by imaging (MRI/PET-CT) and clinical assessment (e.g., digital rectal exam, endoscopy) in patients who forgo immediate surgery.
Measured: 6 months
Secondary outcomes (8)
Major Pathological Response (MPR) Rate
The proportion of participants who undergo surgery and achieve a major pathological response, defined as the presence of ≤10% residual viable tumor cells in the primary tumor.
Measured: 6 months
Objective Response Rate (ORR)
The proportion of participants who achieve a Best Overall Response of either Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 criteria.
Measured: 6 months
Disease Control Rate (DCR)
The proportion of participants who achieve a Best Overall Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) according to RECIST v1.1 criteria.
Measured: 6 months
Progression-Free Survival (PFS)
The time from the start of treatment to the first occurrence of disease progression (radiographically or pathologically confirmed) or death from any cause, whichever occurs first.
Measured: 3 years
Overall Survival (OS)
The time from the start of treatment to death from any cause.
Measured: 5 years
3-Year Event-Free Survival (3y-EFS) Rate
The Kaplan-Meier estimated proportion of participants who remain event-free at 3 years from treatment start. An event is defined as disease progression, local recurrence, distant metastasis, or death from any cause.
Measured: 3 years
3-Year Disease-Free Survival (3y-DFS) Rate
The Kaplan-Meier estimated proportion of participants who remain disease-free at 3 years after surgery. Disease-free survival is defined as the time from surgery to the first occurrence of local or distant recurrence or death from any cause.
Measured: 3 years
Incidence of Adverse Events (AEs)
The frequency and severity of all adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs), graded according to NCI CTCAE v5.0.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start30 Nov 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer, AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongli Liu, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Hongli Liu, Professor, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474103
- Sponsor's protocol ID
- WUGO-003
- Status last verified
- Nov 2025
- First submitted
- 11 Mar 2026
- Last updated
- 16 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Course Radiotherapy Followed by Liposomal Irinotecan, Oxaliplatin, Capecitabine, and Sintilimab as Total Neoadjuvant Therapy in High-Risk Locally Advanced Rectal Cancer: A Single-Arm, Single-Center, Exploratory Study
- ClinicalTrials.gov ID
- NCT07474103
- Acronym / sponsor ID
- WUGO-003
- Conditions
- Rectal Cancer, Adenocarcinoma
- Keywords
- total neoadjuvant therapy, Short-Course Radiotherapy, Liposomal Irinotecan, rectal cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Mar 2026 (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 a single-center, exploratory clinical study for patients with newly diagnosed, high-risk, locally advanced rectal cancer. The study aims to evaluate the effectiveness and safety of a comprehensive pre-surgery (neoadjuvant) treatment strategy.
All participants will receive a short course of radiation therapy (25 Gy in 5 fractions) over one week. This will be followed by a combination of chemotherapy (Liposomal Irinotecan, Oxaliplatin, and Capecitabine) and immunotherapy (Sintilimab). This combined treatment is administered for six cycles.
For patients who achieve a complete response, the option to avoid immediate surgery and enter a close monitoring program ("Watch and Wait") will be considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCRT followed by NALIRIXELOX + Sintilimab | Experimental | Radiation: SCRT, Drug: Liposomal Irinotecan, Drug: Oxaliplatin, Drug: Capecitabine, Drug: Sintilimab1. Short-Course Radiotherapy (SCRT) 2. Systemic Therapy (Chemotherapy + Immunotherapy): Liposomal Irinotecan+Oxaliplatin+Capecitabine+Sintilimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntary Participation: Subjects voluntarily participate in the study, sign the informed consent form, and have good compliance.
- Age and Gender: Age between 18 and 75 years, any gender.
- Pathological Diagnosis: Histologically or cytologically confirmed rectal adenocarcinoma; confirmed mismatch repair proficient (pMMR) or microsatellite stable (MSS) by genetic testing or immunohistochemistry.
- Disease Stage: Assessed as high-risk, mid-low (distance from the anal verge ≤10 cm) locally advanced rectal cancer by colonoscopy, digital rectal exam, or MRI. High-risk definition: Meeting at least one of the following: cT4, extramural vascular invasion (EMVI), tumor deposits, involvement of the mesorectal fascia or intersphincteric plane.
- Prior Treatment: No prior anti-tumor therapy for this rectal cancer (including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy).
Key exclusion criteria (15 listed)
- Other Malignancies: Diagnosis of another malignancy within 5 years prior to the first dose, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ, localized prostate cancer, or papillary thyroid cancer, etc.
- Allergy: Known or suspected allergy to the study drugs or any of their excipients.
- Pregnancy and Lactation: Pregnant or lactating women, or women planning to become pregnant during the study or within 6 months after the last dose.
- Central Nervous System Disease: Known active epilepsy, active central nervous system (CNS) metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
- Significant Cardiovascular Disease: Clinically significant uncontrolled cardiovascular disease.
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 |
|---|---|---|
| SCRTAlso: Short-Course Radiotherapy25 Gy / 5 F | Radiation | SCRT followed by NALIRIXELOX + Sintilimab |
| Liposomal IrinotecanAlso: Nal-IRI, irinotecan liposome50 mg/m², intravenously (IV) on Day 1 of each cycle. | Drug | SCRT followed by NALIRIXELOX + Sintilimab |
| OxaliplatinAlso: OX85 mg/m², IV on Day 1 of each cycle. | Drug | SCRT followed by NALIRIXELOX + Sintilimab |
| CapecitabineAlso: Xeloda800 mg/m², orally twice daily from Day 1 to Day 14 of each cycle. | Drug | SCRT followed by NALIRIXELOX + Sintilimab |
| SintilimabAlso: IBI308200 mg, IV on Day 1 of each cycle. | Drug | SCRT followed by NALIRIXELOX + Sintilimab |
Primary outcome
Complete Response Rate
Time frame: 6 months
The proportion of participants achieving either a Pathologic Complete Response (pCR) or a Clinical Complete Response (cCR). pCR is defined as the absence of viable tumor cells in the primary tumor and lymph nodes (ypT0N0) upon pathological examination after surgery. cCR is defined as the absence of residual tumor as confirmed by imaging (MRI/PET-CT) and clinical assessment (e.g., digital rectal exam, endoscopy) in patients who forgo immediate surgery.
8 secondary outcomes
Major Pathological Response (MPR) Rate
Time frame: 6 months
Objective Response Rate (ORR)
Time frame: 6 months
Disease Control Rate (DCR)
Time frame: 6 months
Progression-Free Survival (PFS)
Time frame: 3 years
Overall Survival (OS)
Time frame: 5 years
3-Year Event-Free Survival (3y-EFS) Rate
Time frame: 3 years
3-Year Disease-Free Survival (3y-DFS) Rate
Time frame: 3 years
Incidence of Adverse Events (AEs)
Time frame: 6 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 16 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.
Hongli Liu, Professor principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCRT, Liposomal Irinotecan and Oxaliplatin in people with Rectal Cancer, Adenocarcinoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 12 inclusion and 15 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 16 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.
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 Hongli Liu, Professor (13995680822, hongli_liu@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (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 16 Mar 2026.