Rectal cancer
Conditions
Interventions
trial group:Combination therapy with pembrolizumab during neoadjuvant therapy
control group:Conventional neoadjuvant therapy
Sponsors
Zhengzhou University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Voluntarily sign the informed consent form for this study; 2) Male or female patients aged 18-75 years old; 3) Confirmed by pathological (histological or cytological) examination as locally advanced rectal cancer (including mucinous adenocarcinoma, signet ring cell carcinoma, etc.); 4) Screen patients with high scores using the pro-inflammatory pan macrophage subpopulation scoring criteria; 5) According to RECIST 1.1, there must be at least one measurable or assessable lesion; Measurable lesions should not have received local treatment such as radiotherapy (periintestinal lymph node imaging indicates metastasis, with a minimum allowable diameter of >= 10mm, and can also be selected as target lesions); 6) ECOG score: 0-1 points; 7) Expected lifespan >= 3 months; And according to the MDT in the hospital, neoadjuvant therapy (or T3-4/N+M0 for middle and low rectal cancer) is considered necessary; 8) The organ function is sufficient, and the following laboratory test values are required during screening: (1) The blood routine examination standards must comply with: Hemoglobin content (HB) >= 90g/L; Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; Platelet count (PLT) >= 100 × 10^9/L (no use of interleukin-11 or TPO within 14 days); (2) Biochemical tests must meet the following standards: Serum total bilirubin (TBIL) = 60ml/min (Cockcroft Gault formula); Serum albumin >= 25 g/L (2.5 g/dL) (3) Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) >= lower limit of normal (50%). (4) Adequate coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) = 90g/L, and to rule out severe gastrointestinal bleeding.
Exclusion criteria
Exclusion criteria: 1) Allergy to any investigational drug or its excipients, or a history of severe allergies, or contraindications to the investigational drug; 2) Has a history of autoimmune diseases or is in an active phase; 3) Symptomatic/Asymptomatic Brain Metastasis; 4) Serious gastrointestinal bleeding is considered clinically (for patients with positive fecal occult blood, the researcher will determine whether it is severe gastrointestinal bleeding based on their overall condition); 5) Individuals with pre-existing autoimmune thyroiditis who require intervention; 6) Previously received allogeneic bone marrow transplantation or organ transplantation; 7) Congenital pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia, or CT confirmed active pneumonia; 8) HIV positive or active hepatitis C (HCV antibody or HCV RNA), active tuberculosis; 9) Hepatitis B surface antigen is positive and hepatitis B virus DNA value exceeds 2000IU/ml; 10) Within 4 weeks prior to the start of the study, the individual has received a live attenuated vaccine, or is expected to receive a live attenuated vaccine during the trial or within 5 months after the trial ends; 11) Previous treatment with PD-1/PD-L1 antibodies, CTLA-4 antibodies, or other inhibitors targeting PD-1/PD-L1 and/or VEGFR; 12) Apply high-dose corticosteroids or immunosuppressants systemically within 2 weeks before the start of the experiment. 13) Contraindications for hormone use; 14) There are multiple factors that can affect oral medication, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 15) Infections that require intravenous antibiotics within 14 days prior to the start of the experiment; 16) Chronic enteritis; 17) Patients with any severe and/or uncontrolled illnesses; 18) Long term untreated wounds or fractures; 19) Unable to accept peripheral central venous catheterization (PICC) or central venous catheterization; 20) Having undergone major surgical procedures (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of the study, or expecting to undergo major surgery during the study treatment period, or non diagnostic surgery within 4 weeks prior to the start of the trial; 21) History of gastrointestinal perforation and/or fistula occurring within the 6 months prior to enrollment for treatment; Or those who have experienced serious arterial/venous thrombotic events, such as cerebrovascular accidents (excluding stable cerebral infarction evaluated by researchers), severe deep vein thrombosis, and pulmonary embolism (patients who only require oral anticoagulant therapy after specialized evaluation of pulmonary embolism events may be considered for inclusion); 22) Clinically significant pleural and peritoneal fluid, including any pleural or peritoneal fluid that can be detected during physical examination, pleural or peritoneal fluid that has been treated in the past or still requires treatment. (Patients with only a small amount of chest and ascites on imaging but no symptoms, assessed by the researcher as not requiring treatment, may be included); 23) Suffering from interstitial lung disease that requires steroid hormone therapy; 24) Uncontrolled metabolic disorders or secondary reactions to other organ or systemic diseases or cancers that may lead to higher medical risks and/or uncertain survival evaluations; 25) Patients with significant malnutrition; 26) Individuals with a history of abuse of psychotropic drugs who are unable to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Disease control rate, DCR; | — |
Countries
China
Contacts
Public ContactNing Li
Zhengzhou University Affiliated Cancer Hospital
Outcome results
None listed