Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study evaluates the addition of immunotherapy of PD-1 antibody in neoadjuvant chemoradiotherapy in microsatellite stable (MSS) locally advanced rectal cancer (LARC). A total of 50 MSS LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX. The tumor response grade, adverse effects and long-term prognosis will be analyzed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | A total of 50 MSS LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 antibody | Drug | Before neo-CRT: 2 cycles of PD-1 antibody, 240mg d1 q2w. After neo-CRT: 3 cycles of PD-1 antibody, 240mg d1 q2w. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response Rate | Pathologic Complete Response Rate | The pathologic complete response rate was evaluated after surgery, which was scheduled 7-8 weeks after the end of chemoradiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | 3 year disease free survival rate | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. |
| Local recurrence free survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhen zhang, M.D, PH.D | Contact | 18801735029 | 18801735029 | zhen_zhang@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| zhen zhang, M.D, PH.D | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhen Zhang | Shanghai | Shanghai Municipality | 200032 | China |
Not provided
| ID | Term |
|---|---|
| C000711728 | spartalizumab |
| D000069287 | Capecitabine |
| D000077146 | Irinotecan |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Capecitabine | Drug | During neo-CRT: 625mg/m2 bid Monday-Friday per week |
|
|
| Irinotecan | Drug | During neo-CRT: 80mg/m2 qw (UGT1A1*28 6/6) or 65mg/m2 qw (UGT1A1*28 6/7) |
|
| Neoadjuvant Radiotherapy | Radiation | IMRT DT: 50Gy/25Fx |
|
3 year local recurrence free survival rate
| From date of randomization until the date of first documented pelvic failure, assessed up to 36 months. |
| Overall survival | 3 year overall survival rate | From date of randomization until the date of death from any cause, assessed up to 36 months. |
| Adverse effects | Chemoradiation-related or immunotherapy-related adverse events | From date of randomization until the date of death from any cause, assessed up to 5 years |
| Surgical complications | Surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc. | The surgery was scheduled 7-8 weeks after the end of chemoradiotherapy. And the surgical complications were assessed up to 5 years from the surgery. |
| Performance Status (Zubrod-ECOG-WHO method), range 0-5. The higher scores mean a worse quality of life. | Quality of life will be evaluated | From date of randomization until the date of death from any cause, assessed up to 10 years |
| Karnofsky Performance Status, range 0-100. The higher scores mean a better quality of life. | Quality of life will be evaluated | From date of randomization until the date of death from any cause, assessed up to 10 years |
| Quality of Life Scale, range 0-60. It evaluates the quality of life from 12 aspects, including appetite, mental status, sleep quality, fatigue, etc. The higher scores mean a better quality of life. | Quality of life will be evaluated | From date of randomization until the date of death from any cause, assessed up to 10 years |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |