pMMR/MSS locally advanced rectal cancer
Conditions
Interventions
treatment group :The intervention measures in this study were divided into three stages: (1) induction treatment stage: mFOLFOX6 combined with envafolimab treatment for 2 cycles
(2) Concurrent chemoradiotherapy: IMRT radiotherapy, concurrent oral capecitabine and injectable envolizumab treatment
? Consolidation treatment stage: mFOLFOX6 combined with envafolimab treatment for 2 cycles
(Note: See the detailed drug treatment plan for the use of the above drugs)
Sponsors
Yunnan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Disease characteristics • Histologically confirmed rectal adenocarcinoma; Immunohistochemical confirmation as pMMR or/and pCR or/and NGS test as MSS; • Tumor location within 12cm from anal margin; • Locally advanced rectal cancer (stage II-III, i.e. cT3-4 and/or N+) as assessed by the UICC/AJCC TNM staging system (8th edition, 2017); * Preoperative staging method: pelvic MRI/ transrectal ultrasound combined with preoperative staging. • No signs of intestinal obstruction; Or intestinal obstruction has been relieved after proximal colostomy surgery; • Preoperative chest, abdominal and pelvic CT to exclude distant metastasis. 2) Patient characteristics • Age: 18 ~75 years old; • Activity status score: ECOG 0-1; • Life expectancy: more than 2 years; • Hematology: WBC>3500×106/L; PLT>100000×106/L; Hb>10g/dL; • Liver function: SGOT and SGPT are less than 1.5 times of normal value; Bilirubin less than 1.5mg/dL; • Kidney function: creatinine <1.8mg/dL; • Other: non-pregnant or breastfeeding women; No other malignant disease (other than non-melanoma or carcinoma in situ of the cervix) within 5 years or during the same period; Does not have a mental illness that prevents informed consent; There were no other serious diseases associated with shorter survival. • Patients or family members can understand the study protocol and are willing to participate in the study, and sign a written informed consent; • Good patient compliance, voluntary follow-up, treatment, laboratory tests, and other research steps as scheduled. 3) Prior treatment • No previous rectal cancer surgery; • No previous chemotherapy or radiation therapy; • No previous biotherapy; • Previous endocrine therapy: No restriction.
Exclusion criteria
Exclusion criteria: • CRC for microsatellite highly unstable (MSI-H) or mismatch repair protein expression deficiency (dMMR); • Chronic hepatitis B or C with a history or active HIV infection (high copy of viral DNA); • Autoimmune diseases; • Other active clinical serious infections (>NCI-CTC version 3.0); • Stage I patients; • Preoperative evidence of distant metastasis; • Dysfluid, organ function decompensation; • A history of pelvic or abdominal radiotherapy; • Multiple primary cancers; • Patients whose seizures require management (such as steroid or antiepileptic therapy); • A history of other malignancies within 5 years, except for cured cervical carcinoma insitu or skin basal cell carcinoma; • Chronic inflammatory bowel disease, intestinal obstruction; Substance abuse and medical, psychological or social conditions that may interfere with the patient's participation in the study or the evaluation of the findings; • A known or suspected allergy to the study drug or to any drug administered in connection with this trial; • Any unstable conditions or conditions that could compromise patient safety and compliance;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective remission rate;Clinical complete response rate;Tumor regression rate;Tumor pathological downphase rate;Tumor regression grade;R0 removal rate;rate of anal preservation;Incidence of surgical complications;2-year disease-free survival rate;Overall survival at 2 years;Patient's quality of life (including anal sphincter function, bladder function, and sexual function);Incidence of adverse reactions;Incidence of serious adverse reactions; | — |
Countries
China
Contacts
Public ContactYunfeng Li
Yunnan Cancer Hospital
Outcome results
None listed