The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSI-H Locally Advanced Rectal Cancer

Disease free survival

3 year disease free survival rate

Time frame: 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

3 year local recurrence free survival rate

Time frame: From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.

Overall survival

3 year overall survival rate

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: From date of randomization until the date of death from any cause, assessed up to 10 years