phase II clinical trial to evaluate node-sparing short-course radiation combined with total neoadjuvant CAPOX and Sintilimab for MSS locally advanced rectal cancers.
This is an open-label, prospective, single-center phase II clinical trial to evaluate node-sparing short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with total neoadjuvant CAPOX and PD-1 Inhibitor (Sintilimab) for patients with MSS locally advanced of middle and low rectal cancer. A total of 47 patients will be enrolled in this trial. The primary endpoint is the complete response(CR) rate, which includes cCR and pCR. The organ preservation rate, tumor regression grade, 3-year DFS, 3-year OS, and adverse effects will also be analyzed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
5Gy\*5d, radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes
200mg intravenous infusion d1 of each cycle\*8cycles
1000mg/m2, PO, BID, d1-14 of each cycle\*8cycles
Zhejiang University Affiliated Jinhua Hospital
Jinhua, Zhejiang, China
RECRUITINGComplete response
Pathological complete response (pCR) :absence of residual tumour on resected specimen. Clinical complete response(cCR): no residual tumour visible on imaging or colonoscopy and biopsy.
Time frame: within 10 days after TNT therapy or surgery
Tumor regression grade
TRG is evaluated according to the AJCC system. TRG0-1 is defined as good response, TRG2 as moderate response, and TRG3 as poor response.
Time frame: within 10 days after surgery
Local recurrence rate(LRR)
Presence of adenocarcinoma within the rectal wall or within the mesorectum confirmed by pathology.
Time frame: 3 years after sugery
Disease free survival(DFS)
the time from randomization to recurrence of tumor or death
Time frame: 3 years after treatment
Overall survival(OS)
the time from randomization to death
Time frame: 3 years after enrollment
Adverse effects rate
Rate of radiotherapy, chemotherapy and immunotherapy related adverse events
Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 5 years
Rectal specific quality of life assessment via QLQ-CR29
Rectal specific quality of life according to European Organization for Research and Treatment of Cancer ( EORTC) Quality of life questionnaire QLQ-CR29. scale from 0 to 100, A higher scale represents better function and a higher quality of life.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
130mg/m2, intravenous infusion,d1 of each cycle\*8cycles
laparoscopic or robotic TME surgery for non-cCR patients
WW for cCR patients
Time frame: Baseline and months 3, 6, 12, 24, 36, 60 after the TNT treatment or surgery
Quality of life assessment via QLQ-C30
Quality of life according to EORTC Quality of life Questionnaire QLQ-C30 version 3.0. Score range from 0 to 100 points. A higher score represents better function and a higher quality of life.
Time frame: Baseline and months 3, 6, 12, 24, 36, 60 after the TNT treatment or surgery
Validation of the Wexner score
The change of severity of fecal incontinence assessment according to Wexner score. a score from 0-20, where 0 is perfect continence and 20 is complete incontinence.
Time frame: Months 3, 6, 12, 24, 36, 60 after the TNT treatment or surgery