Previously, preliminary results, from a subgroup analysis of STARS-RC03 (NCT04906044) conducted by our research team, showed that the 6-cycles consolidation chemotherapy combining with anti-PD-1 therapy had a better tumor regression advantage with a restricted safety profile contrasted with 3-cycle counterparts. Herein, we designed this study to further evaluate the short-term efficacy (such as pCR rate, R0 resection rate, etc.) and long-term survival (including DFS, OS, etc.) of 6-cycles consolidation therapy.
The combination of total neoadjuvant treatment (TNT) and immunotherapy has shown a significant improvement in the pCR rate compared to the standard of care (SOC) or TNT alone for pMMR LARC. On this basis, we believe that this treatment mode will offers the opportunity of organ preservation for subperitoneal "Bad" or "Advanced" patients with LARC, who are initially assessed as unresectable or difficult to obtain R0 resection. Previously, preliminary results, from a subgroup analysis of STARS-RC03 (NCT04906044) conducted by our research team, showed that the 6-cycles consolidation chemotherapy combining with anti-PD-1 therapy had a better tumor regression advantage with a restricted safety profile contrasted with 3-cycle counterparts. Herein, we designed this study to further evaluate the short-term efficacy (such as pCR rate, R0 resection rate, etc.) and long-term survival (including DFS, OS, etc.) of 6-cycles consolidation therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Radiation: Long-course chemoradiotherapy is delivered in 50 Gy/25 fractions with concurrent Capecitabine (825mg/m2, P.O. Bid, 5d/w). Drug: CapeOX (Capecitabine 1000mg/m2, P.O. Bid, d1-d14, q3w; Oxaliplatin 130mg/m2, i.v., d1, q3w), and Sintilimab (200mg, i.v. , d1). Surgical Approach: TME surgery, The surgical approach can be open, laparoscopic or robotic depending on the patient.
First Hospital of Jilin University
Changchun, Jilin, China
Complete response rate (CR)
defined as clinical complete response (cCR) or pathologic complete response (pCR) achieved after neoadjuvant therapy.
Time frame: Within one week after Last treatment
Disease-Free Survival (DFS)
1/2/3 years disease-free survival
Time frame: 1/2/3 years from the date of receiving neoadjuvant therapy
Recurrence -Free Survival (RFS)
1/2/3 years recurrence -free survival
Time frame: 1/2/3 years from the date of receiving neoadjuvant therapy
Overall Survival (OS)
3 years overall survival
Time frame: 3 years from the date of receiving neoadjuvant therapy
Local Recurrence (LR) Rate
2-year local recurrence rate
Time frame: 2 years from the date of receiving neoadjuvant therapy
Organ preservation rate
Organ preservation rate
Time frame: 1/2/3 years from the date of receiving neoadjuvant therapy
R0 Resection rate
R0 Resection rate
Time frame: Within one week after surgery
The incidence of serious adverse events
Any treatment-related grade 3 or higher non-hematological adverse event determined by CTCAE version v 5.0.
Time frame: Within 3 months after Last medication
QLQ-C30 score
Quality of Life Questionnaire C30
Time frame: up to 12 months
QLQ-C29 score
Quality of Life Questionnaire C29
Time frame: up to 12 months
Low Anterior Resection Syndrome (LARS)
Low Anterior Resection Syndrome Questionnaire
Time frame: up to 12 months
Quality of life and function assessment
IIEF-5 (international questionnaire of erectile function-5)score
Time frame: up to 12 months
Wexner score
Wexner incontinence score
Time frame: up to 12 months
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