Rectal Cancer
Conditions
Interventions
Neoadjuvant therapy group:Short-course radiotherapy was performed first: 25 Gy/5 fractions/1 week, followed by immune combined chemotherapy, envafolimab: 300 mg, subcutaneous injection, d1, Q3W, simul
capecitabine 1000 mg/m2, twice daily (bid), orally, d1-14, Q3W.Finally surgery was performed.
Sponsors
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. patients voluntarily participate in this study, good compliance, can cooperate with the trial requirements to complete the observation and follow-up, and sign the informed consent form; 2. aged 18 to 60 years (when signing the informed consent form); 3. ECOG = 2; 4. expected survival time = 12 weeks; 5. the study site pathology department enteroscopy tissue samples immunohistochemical detection diagnosis of pMMR, or genetic testing diagnosis of MSS (PCR or NGS); 6. staging T3-4N0M0 or T1-4N+M0; 7. the lower edge of the lesion meets one of the following conditions: a) within 10 cm from the anal hilum b) MRI sagittal view showed below the peritoneal reflection plane 8. did not receive other anti-tumor drug treatment other than the test drug in the previous 4 weeks, and can receive specialist anti-tumor treatment; 9. at least one measurable lesion: at least one accurately measured diameter (recorded as the maximum diameter), the minimum length of the lesion is as follows: CT scan 10 mm (CT scan slice thickness is not more than 5 mm); Malignant lymph nodes: Pathologically enlarged and measurable lymph nodes must be = 15 mm in short axis on CT scan (CT scan slice thickness recommended to be no greater than 5 mm). 10. good major organ function 11. fertile subjects must use appropriate methods of contraception during this study and 120 days after the end of the study, have a negative serum pregnancy test within 7 days before study enrollment, and must be non-lactating subjects
Exclusion criteria
Exclusion criteria: 1. M1 (one or more distant sites, organs or peritoneal metastasis); 2. Lateral lymph node metastasis; 3. Rectal cancer surgery other than fistulization before enrollment; 4. Previous PD-1/PD-L1 inhibitor therapy and any anti-tumor treatment; 5. Previous history of malignant tumors (except cured cervical carcinoma in situ, cutaneous basal cell carcinoma and squamous cell carcinoma, superficial bladder cancer, early thyroid cancer); 6. Other conditions considered unsuitable by the physician in charge; 7. Severe metamorphosis/allergic reactions to humanized antibodies or fusion protein; 8. Female patients who are pregnant, lactating, and fertile without contraceptive measures; 9. Diagnosis of immunodeficiency or are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days before the first dose of the study, physiological doses of glucocorticoids (= 10 mg/day prednisone or equivalent drugs) are allowed; 10.Subjects with active, known or suspected autoimmune diseases (eg, interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hypothyroidism, including but not limited to these diseases or syndromes) were excluded.Subjects with type I diabetes, hypothyroidism requiring only hormone replacement therapy, skin disease not requiring systemic therapy (eg, vitiligo, psoriasis, or alopecia), or who are not expected to reproduce in the absence of external triggers may be enrolled; 11.Patients with pre-existing severe heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe valvular heart disease; 12.Presence of active hepatitis B (HBV DNA ? 2000 IU/ml or 104copies/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA above the lower limit of detection of the analytical method). 13. Active pulmonary tuberculosis (TB) infection is judged based on chest X-ray, sputum examination, and clinical examination. Patients with a history of active pulmonary tuberculosis infection within the previous year, even if treated, were excluded; patients with a history of active pulmonary tuberculosis infection more than 1 year ago, unless the course and type of anti-tuberculosis treatment previously used were proven to be appropriate. 14. Major surgical treatment, incision biopsy or obvious traumatic injury within 28 days before grouping; 15. Imaging showed that the tumor had invaded important blood vessels or the tumor was very likely to invade important blood vessels during the subsequent study period and cause fatal bleeding; 16. Patients with any signs or history of bleeding constitution regardless of severity; within 4 weeks before grouping, patients with any bleeding or bleeding events = CTCAE grade 3 had unhealed wounds, ulcers or fractures; 17.6 months had hyperarterial/venous thrombotic events, such as cerebrovascular accidents (including temporary ischemic attacks), deep venous thrombosis and pulmonary embolism; 18. Patients with uncontrollable neurological, psychiatric disorders or mental disorders, poor compliance, and inability to cooperate and describe treatment responses; 19. According to the investigator 's judgment, patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;1/2/3 year disease free survival rate;1/2/3 year overall survival rate;Safety and tolerability;Quality of life; | — |
Countries
China
Contacts
Public ContactWang Xishan
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Outcome results
None listed