Rectal cancer
Conditions
Interventions
Experimental group:Tislelizumab plus concurrent short course radiotherapy followed by tislelizumab combined with mFOLFOX6 chemotherapy.
Sponsors
Weifang People’s Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with cT3-4N0M0 or cT1-4N+M0 with histologically confirmed cT3-4N0M0 or cT1-4N+M0 whose lower margin of the tumor was 10 cm or less from the anus prior to treatment for first diagnosis of rectal adenocarcinoma; (2) Patients who have agreed to participate in this study and signed an informed consent form; (3) ECOG score 0 or 1 at enrollment; (4) Patients without distant metastases on imaging within 2 weeks before starting treatment; (5) Females of childbearing potential must voluntarily use highly effective contraception during the study period and for >=365 days after the last antitumor treatment, and have a negative urine or serum pregnancy test result within =365 days after the last antitumor treatment.
Exclusion criteria
Exclusion criteria: (1) Patients with locally recurrent malignant tumors of the rectum or primary tumors with distant metastases; pathological types other than adenocarcinoma or unclear; physical conditions that cannot tolerate surgery, radiotherapy, and chemotherapy and immunotherapy; and patients with combined second primary tumors; (2) Patients with a history of pelvic radiotherapy; (3) Patients with a history of inflammatory bowel disease; (4) Patients with a history of pneumonia or interstitial lung disease; (5) Patients with autoimmune disease or a history of chronic or recurrent autoimmune disease; (6) Patients requiring systemic corticosteroid or immunosuppressive therapy who have received these treatments within 14 days prior to inclusion in the study; (7) History of thyroid dysfunction; (8) Patients with a history of cardiovascular risk for any of the following: patients with a left ventricular ejection rate of less than 50%. Exception: patients with well-controlled atrial fibrillation for more than 30 days prior to enrollment may be enrolled; (9) History of acute coronary syndrome, coronary angioplasty, or stent placement within 6 months of enrollment; (10) Have class II or worse congestive heart failure (according to the New York Heart Association functional classification); (11) Patients treated with implantable cardioverter defibrillators or permanent pacemakers with poorly controlled diabetes or other diseases or other conditions that may interfere with toxicity assessment; (12) Patients with HIV1 antibodies, HIV2 antibodies, HTLV1 antibodies, HBs antigens, or other conditions that may interfere with toxicity assessment; (13) Patients who are pregnant or breastfeeding; (14) Patients with severe unstable mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete remission(pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival(OS);Disease free survival(DFS);Local recurrence free survival(LRFS);Treatment-related adverse event(TRAE);Immune-related adverse effects(IRAE); | — |
Countries
China
Contacts
Public ContactFurong Hao
Weifang People’s Hospital
Outcome results
None listed