rectal cancer
Conditions
Interventions
Treatment group:involved site short-course radiotherapy + CAPOX chemotherapy + envolizumab
Sponsors
Zhujiang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Subjects voluntarily enrolled in this study, signed an informed consent form, had good compliance, and were willing to follow up for review; (2) Age: 18-75 years old; (3) Eastern Cooperative Oncology Group (ECOG) score: =1; (4) Patients with cT2-T4N+M0 or T3-T4N0M0 stage rectal adenocarcinoma confirmed by pathologic histology; (staging based on the 8th edition of the UICC/AJCC TNM staging system in 2017) (5) No antitumor therapy or immunotherapy prior to enrollment; (6) Patients with low and intermediate rectal cancer with the lower cut edge of the tumor = 10 cm from the anal verge diagnosed by rectal fingerprinting, colonoscopy and pelvic high-resolution MRI; (7) Immunohistochemical staining analysis of MMR protein expression or MSI gene testing of pretreatment rectal cancer specimens confirmed as microsatellite stabilization/mismatch gene repair intact MSS/pMMR; (8) No signs of distant metastasis on CT scan and physical examination; (9) Planned surgical treatment after neoadjuvant therapy; (10) No serious hematologic, cardiac, pulmonary, hepatic, or renal functional abnormalities or immunodeficiency diseases; (11) Laboratory tests need to be fulfilled: ? Blood routine: (no blood transfusion or correction with hematopoietic stimulating factor drugs within 7 days prior to screening): a) Hemoglobin = 90g/L; b) Leukocyte count =3×109/L; c) Absolute neutrophil count = 1.5 × 109/L; d) Platelet count =100×109/L; ? Biochemical examination: a) Total bilirubin (TBIL) =1.5 times upper limit of normal (ULN); b) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 × ULN; c) Serum creatinine (CR) = 1.5 ULN or creatinine clearance (CCR) = 50 mL/min; d) Serum albumin = 28 g/L; ? Coagulation and thyroid function: a) International Normalized Ratio (INR) = 1.5 x ULN; Activated Partial Thromboplastin Time (APTT) = 1.5 x ULN (no anticoagulant therapy received); b) Thyrotropin level = 1 × ULN or T3 and T4 levels within normal range. (12) Reproductively capable males or females willing to use contraception in the trial.
Exclusion criteria
Exclusion criteria: (1) Prior exposure to any anti-PD-1 or anti-PD-L1 antibodies, received chemotherapy; (2) Prior history of pelvic radiotherapy; (3) Prior history of invasive rectal malignancy; (4) Patients requiring treatment with corticosteroids at doses equivalent to prednisone >2 mg/d or other immunosuppressive agents within 2 weeks prior to study drug administration; (5) Known dihydropyrimidine dehydrogenase (DPD) deficiency; (6) Known hypersensitivity to the active ingredients, excipients contained in the investigational drugs of this study (PD-1/PD-L1 monoclonal antibody, oxaliplatin, capecitabine) and other platinum drugs, or a history of severe allergy to any other monoclonal antibody; (7) Patients with previous history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; (8) HIV-infected patients, patients with active hepatitis B or hepatitis C (reference for active hepatitis B: HBV DNA =104 copies/mL; reference for hepatitis C: HCV RNA =103 copies/mL); (9) Patients with interstitial lung disease (ILD ,including past and present medical history), such as interstitial pneumonia and pulmonary fibrosis, or evidence of ILD on baseline chest CT or MRI; (10) Combined severe cardiac, pulmonary, hepatic, and renal insufficiency; (11) Patients with medical contraindications to magnetic resonance imaging MRI or second primary malignancies; (12) Receipt of live attenuated vaccine within 4 weeks prior to initiation of treatment; (13) Undergoing major surgery or severe trauma within 4 weeks prior to starting treatment; (14) Women who are breastfeeding, pregnant, or preparing for pregnancy; (15) Patients with cognitive impairment/abnormal mental status and poor compliance with treatment. (16) Other conditions that, in the judgment of the investigator, make enrollment inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor regression grade;R0 excision rate;overall survival;Progression-free survival;Incidence of treatment-related adverse events; | — |
Countries
China
Contacts
Public ContactLi Jiqiang
Zhujiang Hospital of Southern Medical University
Outcome results
None listed