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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCRT followed by NALIRIXELOX + Sintilimab | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCRT | Radiation | 25 Gy / 5 F |
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| Measure | Description | Time Frame |
|---|---|---|
| Complete 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongli Liu, Professor | Contact | 13995680822 | hongli_liu@hust.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hongli Liu, Professor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hongli Liu | Recruiting | Wuhan | China |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C584112 | irinotecan sucrosofate |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| C000632826 | sintilimab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
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| Liposomal Irinotecan | Drug | 50 mg/m², intravenously (IV) on Day 1 of each cycle. |
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| Oxaliplatin | Drug | 85 mg/m², IV on Day 1 of each cycle. |
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| Capecitabine | Drug | 800 mg/m², orally twice daily from Day 1 to Day 14 of each cycle. |
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| Sintilimab | Drug | 200 mg, IV on Day 1 of each cycle. |
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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. |
| 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. | 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. | 3 years |
| Overall Survival (OS) | The time from the start of treatment to death from any cause. | 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. | 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. | 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. | 6 months |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |