Treatment-naïve patients with locally advanced rectal adenocarcinoma without prior exposure to any antitumor therapy.
Conditions
Interventions
Neoadjuvant NALIRI-CAP and sintilimab followed by short-course radiotherapy:Neoadjuvant NALIRI-CAP and sintilimab followed by short-course radiotherapy
Sponsors
Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years (inclusive) at the time of signing the informed consent form, regardless of gender. 2. Pathologically confirmed rectal adenocarcinoma with clinical stage II–III deemed resectable, and baseline clinical stage of cT3-4 or N+, M0, according to the 8th edition of the UICC/AJCC TNM staging system (2017) (specifically: cT3–4, N0, M0 or cT1–4, N1–2, M0). 3. Confirmed tumor location with the lower margin of the tumor = 12 weeks. 8. No contraindications to surgery. 9. Adequate baseline organ function to meet the requirements of combination therapy, including essentially normal peripheral blood counts, no significant abnormalities in cardiac, hepatic, or renal function, and essentially normal electrocardiogram (ECG). 10. Voluntarily agrees to participate in the study, provides written informed consent, and is willing and able to comply with the scheduled study visits and other protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Has a history of malignancy other than colorectal cancer within 5 years prior to screening, with the exception of curatively treated cutaneous basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ, or other malignancies deemed by the investigator to have a low risk of metastasis and mortality. 2. Has a history of malignancy other than colorectal cancer within 5 years prior to screening, with the exception of curatively treated cutaneous basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ, or other malignancies deemed by the investigator to have a low risk of metastasis and mortality. 3. Has previously received treatment with immune checkpoint inhibitors, including anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, or any other cellular immunotherapy. 4. Has previously received irinotecan or irinotecan liposome-based chemotherapy. 5. Has used strong inhibitors or inducers of CYP3A4, CYP2C8, or UGT1A1 within 14 days prior to the start of study treatment. 6. Has participated in another interventional clinical trial within 4 weeks prior to the start of study treatment, with the exception of observational (non-interventional) clinical studies or follow-up periods of interventional studies. 7. Has clinically documented severe gastrointestinal disorders (including hemorrhage, obstruction; inflammation > Grade 2 per NCI-CTCAE v5.0; diarrhea > Grade 1 per NCI-CTCAE v5.0), or other conditions that, in the investigator's judgment, may affect the ingestion, transport, or absorption of the study drugs (including inability to swallow, post-small bowel resection, or total gastrectomy, etc.). 8. Has pleural effusion or ascites requiring clinical intervention (NCI-CTCAE v5.0 >= Grade 2). 9. Has serious concomitant diseases that may preclude treatment with the study drugs. 10. Has had a severe infection (NCI-CTCAE v5.0 > Grade 2) within 4 weeks prior to screening, such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications; or has signs or symptoms of infection requiring intravenous antibiotic therapy within 2 weeks prior to the start of study treatment (with the exception of prophylactic antibiotic use). 11. Has a known allergy, hypersensitivity, or intolerance to any of the study drugs or their excipients, or has any contraindication to any of the study drugs. 12. Is planning to become pregnant, or is pregnant or breastfeeding. 13. Has any other condition that, in the investigator's judgment, would preclude enrollment in this study, including but not limited to other serious diseases (including psychiatric disorders) requiring concomitant treatment, severe abnormalities in laboratory tests, or social or familial factors that may compromise patient safety or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;Sphincter preservation rate;3-year disease-free survival (DFS) rate;R0 resection rate;3-year overall survival (OS) rate;3-year local recurrence-free survival (LRFS) rate; | — |
Countries
China
Contacts
Public ContactLihua Shao
Drum Tower Hospital
Outcome results
None listed