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New treatment option for Advanced Rectal Cancer
Official title Liposomal Irinotecan, Capecitabine and Enlonstobart With Short-Course Radiotherapy for Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT07281157
What this study is testing
What is Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy?
Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy is an investigational medicine, given as an once-daily, being studied as a potential treatment for advanced rectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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;
You likely can't join 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...
- 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...
- patients who underwent major organ surgery (excluding needle biopsy, central venous catheterization, port catheterization, stent placement to relieve...
See the full eligibility criteria
- 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) ≥1.5×10\^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.
- 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)...
- 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...
- 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...
- have hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg);
- people 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, people with fever due to cancer could be...
- people 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...
- 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...
- intestinal obstruction (except incomplete intestinal obstruction requiring only enteral nutrition); people at risk of intestinal perforation (including, but not limited to, a history of acute diverticulitis, abdominal...
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.