Advanced Rectal CancerPhase 2NCT07281157
Liposomal Irinotecan, Capecitabine and Enlonstobart With Short-Course Radiotherapy for Locally Advanced Rectal Cancer
A Phase 2 study testing Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy in people with Advanced Rectal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a prospective, single-center, single-arm study evaluating the combination regimen of liposomal irinotecan, capecitabine, and enlonstobart combined with short-course radiotherapy as neoadjuvant therapy for locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Rectal Cancer
- What is being tested?
- Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 30 Apr 2032
- 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 of 18-75 years old;
- rectal adenocarcinoma confirmed by histology and/or cytology;
- locally advanced rectal cancer cT3-4 or N+ confirmed by baseline examination (AJCC/UICC TNM staging (8th edition, 2017);
- Distance from lower margin to anal margin ≤ 10 cm;
- Patients with at least one assessable lesion according to RECIST1.1 criteria;
- ECOG 0-1;
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- the expected survival time was more than 12 months;
- had not received anti-tumor treatment for rectal cancer after diagnosis, including radiotherapy, chemotherapy, surgery, etc.
- Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10^9/L, hemoglobin ≥90g/dL, platelet (PLT) ≥100×10^9/L, white blood cell (WBC) ≥3.0×10^9/L;
- Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤2.5 times the upper limit of normal (ULN), if there is liver metastasis ≤5×ULN, total bilirubin <1.5 ULN;
- Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60mL/min (according to Cockcroft-Gault formula);
- Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5×ULN;
- exclude active or suspected infection;
- non-pregnant or lactating women; Women/men of childbearing age should use effective contraception during the study and for 6 months after the end of study treatment;
- The patients had good compliance, understood the research process of this study, and signed the written informed consent.
Who cannot join
- patients with other malignant tumors (except cured carcinoma in situ and basal cell carcinoma) in the past 5 years;
- patients with mismatch repair deficiency (dMMR) or microsatellite instability high (MSI-H);
- obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months before treatment (bleeding > 30 mL within 3 months, hematemesis, melena, hematochezia), hemoptysis (fresh blood > 5 mL within 4 weeks), etc. Or treatment for a venous/venous thrombotic event within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Long-term anticoagulation with warfarin or heparin or long-term antiplatelet therapy (aspirin ≥300 mg/ day or clopidogrel ≥75 mg/ day) may be required.
- extensive distant metastasis (e.g., peritoneal metastasis, multiple bone/brain metastases);
- patients who had used potent CYP3A4 inducers at the same time within 3 weeks before the first dose, or had used potent CYP3A4 inhibitors or potent UGT1A1 inhibitors within 3 weeks before the first dose;
- patients who underwent major organ surgery (excluding needle biopsy, central venous catheterization, port catheterization, stent placement to relieve biliary obstruction, percutaneous hepatobiliary drainage, cholecystostomy) or elective surgery within 4 weeks before treatment;
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- tumor invasion of large vascular structures, such as pulmonary artery, superior vena cava or inferior vena cava, and there is a high risk of bleeding according to the investigator's judgment;
- Active heart disease (including myocardial infarction, severe/unstable angina) within 6 months before treatment. Echocardiography showed that the left ventricular ejection fraction was less than 50% and the arrhythmia was not well controlled.
- have hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg);
- subjects with active infection or fever of unknown origin >38.5 degrees during screening or before the first dose of medication (according to the investigator's assessment, subjects with fever due to cancer could be enrolled);
- subjects with congenital or acquired immunodeficiency, such as HIV infection or active hepatitis (transaminase did not meet the inclusion criteria, hepatitis B reference: HBV DNA≥1000 IU/ml; hepatitis C reference: HCV RNA≥1000 IU/ml); Chronic hepatitis B virus carriers, HBV DNA < 2000 IU/ml, must receive antiviral therapy at the same time during the trial.
- any other medical condition, clinically significant metabolic abnormality, physical examination abnormality, or laboratory abnormality where there is reason to suspect that the patient has a disease or condition (such as having seizures requiring treatment) that would be inappropriate for the study drug, in the investigator's judgment, or that would affect interpretation of the study results or place the patient at high risk;
- intestinal obstruction (except incomplete intestinal obstruction requiring only enteral nutrition); Subjects at risk of intestinal perforation (including, but not limited to, a history of acute diverticulitis, abdominal abscess, or abdominal cancer); (14 ) History of wide bowel resection (partial colectomy or wide small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
- Has received any other antibodies/drugs (including PD-1, PD-L1, PD-L2, CTLA-4, OX40, CD137 inhibitors, etc.) acting on T cell co-stimulation or checkpoint pathway.
- patients with CTCAE 5.0 grade ≥ 3 immune-related adverse events (AE) after immunotherapy.
- patients receiving glucocorticoid (prednisone >10mg/ day or equivalent dose of other drugs of the same kind) or other immunosuppressive therapy for some condition within 14 days before the first dose of the drug.
- participated in other clinical investigators within 4 weeks before enrollment; (19) a documented history of allergy to study drugs, including Enlonstobart, capecitabine, liposomal irinotecan, and any component of the drug; (20) pregnant or lactating female subjects; Patients deemed by the investigator to be ineligible for trial participation.
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 & Hospital
Tianjin, Tianjin Municipality, 300000
Rui Liu, MD, +86 13602139003, liurui9003@163.com
About this study
Official title: Liposomal Irinotecan, Capecitabine, and Enlonstobart Combined With Short-Course Radiotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer: A Prospective, Single-Center, Single-Arm Study
This is a prospective, single-center, single-arm study evaluating the combination regimen of liposomal irinotecan, capecitabine, and enlonstobart combined with short-course radiotherapy as neoadjuvant therapy for locally advanced rectal cancer.
- Conditions
- Advanced Rectal Cancer
- Being tested
- Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course RadiotherapyDrug
Phase One: Induction immunotherapy Liposomal irinotecan: 50mg/m2, ivgtt, d1; Capecitabine: 825mg/m2, po, bid, d1-10; Enlonstobart: 240mg, ivgtt, d1. Repeat every two weeks for two treatment cycles
Phase Two: Short-course radiotherapy Short-course radiotherapy: 5x5Gy, once a day, 5Gy each time, for 5 consecutive days. After radiotherapy, rest for 7 to 14 days before starting consolidation immunotherapy. After radiotherapy, conduct imaging evaluations of tumor remission.
Phase Three: Consolidation of chemotherapy-free treatment Liposomal irinotecan: 50mg/m2, ivgtt, d1; Capecitabine: 825mg/m2, po, bid, d1-10; Enlonstobart: 240mg, ivgtt, d1. Repeat every two weeks for four treatment cycles
Phase Four: W\&W
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Irinotecan, Capecitabine, and Enlonstobart Combined with Short-Course Radiotherapy | Experimental | Not described Receives: Drug: Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response plus pathological complete response
Through imaging examinations such as CT, MRI or PET-CT, it was confirmed that all visible tumor lesions had completely disappeared and remained there for at least 4 weeks. After surgical resection of the tumor tissue, no residual cancer cells (including the primary lesion and lymph nodes) were found under microscopic examination.
Measured: 1 year
Secondary outcomes (3)
Progression-free survival
The time from randomization to disease progression or death
Measured: 2 year
OS
The period from the time a patient randomly receives treatment until death due to any cause.
Measured: 3 year
Adverse Event
All adverse medical events that occurred after the subjects accepted the trial protocol.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Nov 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Rectal CancerStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281157
- Sponsor's protocol ID
- CSPC-DNY-CRC-TJ04
- Status last verified
- Oct 2025
- First submitted
- 1 Dec 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Irinotecan, Capecitabine, and Enlonstobart Combined With Short-Course Radiotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer: A Prospective, Single-Center, Single-Arm Study
- ClinicalTrials.gov ID
- NCT07281157
- Acronym / sponsor ID
- CSPC-DNY-CRC-TJ04
- Conditions
- Advanced Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2032 (estimated)
- First posted
- 15 Dec 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 a prospective, single-center, single-arm study evaluating the combination regimen of liposomal irinotecan, capecitabine, and enlonstobart combined with short-course radiotherapy as neoadjuvant therapy for locally advanced rectal cancer.
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, Capecitabine, and Enlonstobart Combined with Short-Course Radiotherapy | Experimental | Drug: Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age of 18-75 years old;
- rectal adenocarcinoma confirmed by histology and/or cytology;
- locally advanced rectal cancer cT3-4 or N+ confirmed by baseline examination (AJCC/UICC TNM staging (8th edition, 2017);
- Distance from lower margin to anal margin ≤ 10 cm;
- Patients with at least one assessable lesion according to RECIST1.1 criteria;
Key exclusion criteria (17 listed)
- patients with other malignant tumors (except cured carcinoma in situ and basal cell carcinoma) in the past 5 years;
- patients with mismatch repair deficiency (dMMR) or microsatellite instability high (MSI-H);
- obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months before treatment (bleeding > 30 mL within 3 months, hematemesis, melena, hematochezia), hemoptysis (fresh blood > 5 mL within 4 weeks), etc. Or treatment for a venous/venous thrombotic event within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Long-term anticoagulation with warfarin or heparin or long-term antiplatelet therapy (aspirin ≥300 mg/ day or clopidogrel ≥75 mg/ day) may be required.
- extensive distant metastasis (e.g., peritoneal metastasis, multiple bone/brain metastases);
- patients who had used potent CYP3A4 inducers at the same time within 3 weeks before the first dose, or had used potent CYP3A4 inhibitors or potent UGT1A1 inhibitors within 3 weeks before the first dose;
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 |
|---|---|---|
| Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course RadiotherapyPhase One: Induction immunotherapy Liposomal irinotecan: 50mg/m2, ivgtt, d1; Capecitabine: 825mg/m2, po, bid, d1-10; Enlonstobart: 240mg, ivgtt, d1. Repeat every two weeks for two treatment cycles Phase Two: Short-course radiotherapy Short-course radiotherapy: 5x5Gy, once a day, 5Gy each time, for 5 consecutive days. After radiotherapy, rest for 7 to 14 days before starting consolidation immunotherapy. After radiotherapy, conduct imaging evaluations of tumor remission. Phase Three: Consolidation of chemotherapy-free treatment Liposomal irinotecan: 50mg/m2, ivgtt, d1; Capecitabine: 825mg/m2, po, bid, d1-10; Enlonstobart: 240mg, ivgtt, d1. Repeat every two weeks for four treatment cycles Phase Four: W\&W | Drug | Liposomal Irinotecan, Capecitabine, and Enlonstobart Combined with Short-Course Radiotherapy |
Primary outcome
Complete response plus pathological complete response
Time frame: 1 year
Through imaging examinations such as CT, MRI or PET-CT, it was confirmed that all visible tumor lesions had completely disappeared and remained there for at least 4 weeks. After surgical resection of the tumor tissue, no residual cancer cells (including the primary lesion and lymph nodes) were found under microscopic examination.
3 secondary outcomes
Progression-free survival
Time frame: 2 year
OS
Time frame: 3 year
Adverse Event
Time frame: 3 year
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 Jun 2026.
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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 Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy in people with Advanced Rectal Cancer, 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 15 inclusion and 17 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 3 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 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 Rui Liu, MD (+86 13602139003, liurui9003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response plus pathological complete response (time frame: 1 year). 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 Jun 2026.