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The study is a prospective, single-center, single-arm, phase II clinical trial. Patients with pelvic recurrent rectal cancer aged from 18 to 75 years, Eastern Cooperative Oncology Group performance status of 0-1, will receive 45-50Gy/25Fx irradiation or 30Gy/15Fx reirradiation (history of pelvic radiation). PD-1 inhibitor (Toripalimab) was used throughout the course of induction chemotherapy (before radiation), concurrent chemoradiation and consolidation chemotherapy (after radiation); radical resection was followed by well-experienced surgeons .
The primary endpoint was pathological complete response (pCR) rate. Secondary endpoints were R0 resection rate, 3-year progression-free survival, overall survival, pathological tumor regression grade, operation characteristics and incidence of major surgical complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | The patients will receive 2 cycles of XELOX or XELIRI and PD-1 antibody, followed by long course radiotherapy (45-50Gy/25f or 30Gy/25f), concurrent with Capecitabine and 1-2 cycles of PD-1 antibody, then receive 2-3 cycles of XELOX or XELIRI and PD-1 antibody. Curative surgery is scheduled after neoadjuvant treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 antibody (Toripalimab) | Drug | PD-1 antibody: (Toripalimab): 240mg q3w |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response rate | Defined as pathological evaluation of resected tumor tissue and regional lymph nodes, with no residual tumor cells, complete disappearance of all tumor lesions, and no appearance of new lesions. | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | Complete resection rate, defined as no residual tumor cells at the surgical margin under the microscope or the naked eye. | up to 1 year |
| 3-year Progression-Free Survival | Defined as the time from the date of start treatment until the date of local recurrence or local recurrence progression or distant metastases or death from any cause or censored at last follow-up within 3 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojian Wu | Contact | 86-020-38455325 | wuxjian@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510655 | 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 |
|---|---|
| C000656314 | toripalimab |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| D000077146 | Irinotecan |
| D011827 | Radiation |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Capecitabine |
| Drug |
Capecitabine:1000mg/m² d1-14 q3w; Capecitabine:825mg/m² on the day of radiotherapy |
|
| Oxaliplatin | Drug | 130 mg/m² q3w |
|
| Irinotecan | Drug | 200 mg/m² q3w |
|
| Radiation | Radiation | 45-50Gy/25Fx or 30Gy/15Fx |
|
| surgery | Procedure | The type of surgery will depend on the site of recurrence and the involvement of adjacent structures, which will be determined by the surgeons. |
|
| up to 3 years |
| Overall Survival | Defined as the time from the date of start treatment until the date of death from any cause or censored at last follow-up. | up to 3 years |
| Pathological tumor regression grading | Classify according to the Mandard tumor regression grading system. | up to 1 year |
| Operation complications | intraoperative complications | up to 1 year |
| Incidence of major surgical complications | From the date of surgery to 3 months after surgery, according to Clavien-Dindo classification score. | up to 3 months |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D055585 | Physical Phenomena |