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. All participants will receive a short course of radiation therapy (25 Gy in 5 fractions) over one week. This will be followed by a combination of chemotherapy (Liposomal Irinotecan, Oxaliplatin, and Capecitabine) and immunotherapy (Sintilimab). This combined treatment is administered for six cycles. For patients who achieve a complete response, the option to avoid immediate surgery and enter a close monitoring program ("Watch and Wait") will be considered.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
25 Gy / 5 F
50 mg/m², intravenously (IV) on Day 1 of each cycle.
85 mg/m², IV on Day 1 of each cycle.
800 mg/m², orally twice daily from Day 1 to Day 14 of each cycle.
200 mg, IV on Day 1 of each cycle.
Hongli Liu
Wuhan, China
RECRUITINGComplete Response Rate
The proportion of participants achieving either a Pathologic Complete Response (pCR) or a Clinical Complete Response (cCR). pCR is defined as the absence of viable tumor cells in the primary tumor and lymph nodes (ypT0N0) upon pathological examination after surgery. cCR is defined as the absence of residual tumor as confirmed by imaging (MRI/PET-CT) and clinical assessment (e.g., digital rectal exam, endoscopy) in patients who forgo immediate surgery.
Time frame: 6 months
Major Pathological Response (MPR) Rate
The proportion of participants who undergo surgery and achieve a major pathological response, defined as the presence of ≤10% residual viable tumor cells in the primary tumor.
Time frame: 6 months
Objective Response Rate (ORR)
The proportion of participants who achieve a Best Overall Response of either Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 criteria.
Time frame: 6 months
Disease Control Rate (DCR)
The proportion of participants who achieve a Best Overall Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) according to RECIST v1.1 criteria.
Time frame: 6 months
Progression-Free Survival (PFS)
The time from the start of treatment to the first occurrence of disease progression (radiographically or pathologically confirmed) or death from any cause, whichever occurs first.
Time frame: 3 years
Overall Survival (OS)
The time from the start of treatment to death from any cause.
Time frame: 5 years
3-Year Event-Free Survival (3y-EFS) Rate
The Kaplan-Meier estimated proportion of participants who remain event-free at 3 years from treatment start. An event is defined as disease progression, local recurrence, distant metastasis, or death from any cause.
Time frame: 3 years
3-Year Disease-Free Survival (3y-DFS) Rate
The Kaplan-Meier estimated proportion of participants who remain disease-free at 3 years after surgery. Disease-free survival is defined as the time from surgery to the first occurrence of local or distant recurrence or death from any cause.
Time frame: 3 years
Incidence of Adverse Events (AEs)
The frequency and severity of all adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs), graded according to NCI CTCAE v5.0.
Time frame: 6 months
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