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New treatment option for Rectal Cancer, Adenocarcinoma
Official title SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARC
ClinicalTrials.gov ID: NCT07474103
What this study is testing
What is Liposomal Irinotecan?
Liposomal Irinotecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for rectal cancer, adenocarcinoma.
Also referred to as Nal-IRI, irinotecan liposome.
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 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.
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
- Voluntary Participation: people 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...
- Disease Stage: Assessed as high-risk, mid-low (distance from the anal verge ≤10 cm) locally advanced rectal cancer by colonoscopy, digital rectal...
- Prior Treatment: No prior anti-tumor therapy for this rectal cancer (including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted...
You likely can't join if
- Other Malignancies: Diagnosis of another malignancy within 5 years prior to the first dose, except for adequately treated basal cell carcinoma...
- 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...
- Significant Cardiovascular Disease: Clinically significant uncontrolled cardiovascular disease.
- History of Allergic Disease: History of allergic diathesis, asthma, or atopic dermatitis.
See the full eligibility criteria
- Voluntary Participation: people 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...
- 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.
- 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...
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life Expectancy: Expected survival time ≥3 months.
- Good organ function.
- Contraception: people of childbearing potential must agree to use effective contraception during the treatment period and for 6 months after the last dose.
- 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...
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, 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 Wuhan, 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.