This study will evaluate the efficacy and safety of SHR-1701 combined with radiotherapy and chemotherapy as perioperative treatment for locally advanced rectal cancer. Eligible patients will receive standard chemoradiation with SHR-1701 followed by XELOX combined with SHR-1701. In all subjects, restaging pelvic MRI with chest and abdominal CT will be performed after completion of neoadjuvant treatment to determine resectability and to rule out any evidence of metastases. Subjects who have resectable disease will undergo surgery. Adjuvant XELOX combined with SHR-1701 will be given after surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Radiation: Radiation therapy 50.4Gy in 28 fractions to the pelvis on Days 1-5 every week. Drug: Capecitabine Capecitabine 825mg/m\^2 orally twice daily (bid) 5 days/week during radiotherapy. Drug:SHR-1701 Drug: Capecitabine (XELOX) Capecitabine 1000mg/m\^2 orally twice daily (bid) day1-day14, q3w. Drug: Oxaliplatin Oxaliplatin 130mg/m\^2, day1, iv, q3w
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGNumber of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: At week 16, DAY1
Percentage of participants with Pathological complete response ( pCR )
Time frame: At week 16, DAY1
Tumor regression grade ( TRG )
Time frame: At week 16, DAY1
Percentage of participants with R0 Resection ( R0 )
Time frame: At week 16, DAY1
Percentage of participants with Clinical complete response ( cCR ) rate.
Time frame: At week 16, DAY1
Event-free survival ( EFS )
Time frame: Year 1, Year 2, Year 3
Overall survival ( OS )
Time frame: Year 1, Year 2, Year 3
Disease-free survival ( DFS )
Time frame: Year 1, Year 2, Year 3
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