Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer（CONTROL-01）

Summary

To evaluate the safety and preliminary efficacy of preoperative chemotherapy and PD-1 inhibitor Tislelizumab for Rectal Cancer patients.Go through laboratory and medical tests to verify eligibility to enter the study, receive the experimental combination of drugs CAPOX (Oxaliplatin and Capecitabine) for 3 cycles prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three years.

Eligibility

Inclusion Criteria:

* Be willing and able to provide written informed consent for the trial
* Age 18 years or greater
* Pathologically proven diagnosis of adenocarcinoma of the rectum
* Clinically determined to be stage T3 or T4, N0-N2, and M0
* Be fully active, able to carry on all pre-disease performance without restriction or Restricted in physically strenuous activity.
* Contrast-enhanced imaging of the abdomen and chest by CT to exclude distant metastases and provide local tumor stage
* Preoperative ECOG status score 0-1
* Preoperative ASA grade I-III
* Adequate bone marrow function
* Adequate renal and liver function
* No active second cancers
* Be willing and able to comply with all aspects of the protocol
* Women of childbearing potential must have used reliable contraception or have had a pregnancy test result within 7 days prior to enrollment. Be negative and willing to use an adequate method of contraception for the duration of the trial and for 8 weeks after the last administration of the trial drug.
* Adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,200 cells/mm3 Platelets ≥ 100,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl.
* Adequate hepatic function within within 28 days before registration on this study:total bilirubin must be ≤ ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation \> ULN to 1.5 x ULN due to Gilbert\'s disease or similar syndrome involving slow conjugation of bilirubin; and AST and ALT must be ≤3 x ULN for the lab If AST and/or ALT is ≥ ULN but ≤ 3 x ULN, serologic testing for Hepatitis B and C must be performed and results for viral infection must be negative.
* Adequate renal function within 28 days before randomization defined as serum creatinine ≤ 1.5 x ULN for the lab or calculated creatinine clearance \> 30 mL/min

Exclusion Criteria:

* Age less than 18 years
* Pregnant or breastfeeding women
* Prior invasive malignancy unless disease free for a minimum of three years
* Preoperative body temperature ≥ 38°C or concurrent infectious diseases requiring systemic therapy;
* Severe mental illness;
* Severe abnormal heart, lung and kidney function
* History of unstable angina pectoris or myocardial infarction within 6 months;
* History of cerebral infarction or cerebral hemorrhage within 6 months;
* Patients with abnormal coagulation function;
* Have a history of psychotropic drug abuse or have a mental disorder;
* Continuous use of glucocorticoids within 1 month (except topical application);
* Patient has participated in or is participating in other clinical studies (within 6 months);
* According to the judgment of the investigator, it endangers the patient\'s health or affects the experimental results.

Conditions2

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