Irinotecan Liposome Plus Capecitabine and Enronsubemab Combined With Short-course Radiotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer

NCT07281157 | Recruiting Phase 2

• 1 other identifier: CSPC-DNY-CRC-TJ04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-center, single-arm study on the combination regimen of irinotecan liposome, capecitabine and enronsubemab embedded in short-course radiotherapy as neoadjuvant therapy for locally advanced rectal cancer.

Conditions

Advanced Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (3)

• Progression-free survival

  2 year

• OS

  3 year

• Adverse Event

  3 year

Study Arms (1)

Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy

EXPERIMENTAL

Drug: Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy

Interventions

Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy DRUG

Phase One: Induction immunotherapy Irinotecan liposome: 50mg/m2, ivgtt, d1; Capecitabine: 825mg/m2, po, bid, d1-10; Enlangsumab: 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 Irinotecan liposome: 50mg/m2, ivgtt, d1; Capecitabine: 825mg/m2, po, bid, d1-10; Enlangsumab: 240mg, ivgtt, d1. Repeat every two weeks for four treatment cycles Phase Four: W\&W

Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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) ≥1.5×109/L, hemoglobin ≥90g/dL, platelet (PLT) ≥100×109/L, white blood cell (WBC) ≥3.0×109/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.

You may not qualify if:

• 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;
• 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);
• 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.
• (15) received any other antibodies/drugs (including PD-1, PD-L1, PD-L2, CTLA-4, OX40, C137 inhibitors, etc.) acting on T cell costimulation or checkpoint pathway.
• (16) patients with CTCAE 5.0 grade ≥ 3 immune-related adverse events (AE) after immunotherapy.
• (17) 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Interventions

irinotecan sucrosofate; Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Rui Liu, MD

CONTACT

+86 13602139003; liurui9003@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 15, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2032
• Last Updated: December 30, 2025

Record last verified: 2025-10

Locations

CN (1)