Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer（CONTROL-01）
Neoadjuvant Chemotherapy and Tislelizumab (PD-1 Inhibitior) for Locally Advanced Rectal Cancer: a Single-center, Prospective, Phase II Study
The Affiliated Hospital of Qingdao University
35 participants
Jun 1, 2025
INTERVENTIONAL
Conditions
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 Criteria16
- 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 Criteria13
- 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.
Interventions
Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) 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 to four years. The time in the study will take approximately four - six hours during pre-study, study and end of study visits.
Locations(1)
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NCT06647680