Actively Recruiting
Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer（CONTROL-01）
Led by The Affiliated Hospital of Qingdao University · Updated on 2026-03-06
35
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer（CONTROL-01）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Age 18 years or older
- Pathologically confirmed adenocarcinoma of the rectum
- Clinically stage T3 or T4, N0-N2, M0
- Fully active or restricted only in physically strenuous activity
- Contrast-enhanced CT imaging of abdomen and chest showing no distant metastases
- Preoperative ECOG score 0-1
- Preoperative ASA grade I-III
- Adequate bone marrow function (ANC ≥ 1,200 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl)
- Adequate liver function (total bilirubin ≤ upper limit normal or ≤ 1.5 x ULN if Gilbert's syndrome; AST and ALT ≤ 3 x ULN; negative Hepatitis B and C if AST/ALT elevated)
- Adequate renal function (serum creatinine ≤ 1.5 x ULN or creatinine clearance > 30 mL/min)
- No active second cancers
- Willing and able to comply with all study procedures
- Women of childbearing potential must use reliable contraception or have a negative pregnancy test within 7 days before enrollment and continue contraception during the trial and for 8 weeks after last drug dose
You will not qualify if you...
- Age under 18 years
- Pregnant or breastfeeding women
- Prior invasive malignancy unless disease-free for at least 3 years
- Preoperative body temperature ≥ 38°C or active infections requiring systemic treatment
- Severe mental illness
- Severe abnormal heart, lung, or kidney function
- History of unstable angina or myocardial infarction within 6 months
- History of cerebral infarction or hemorrhage within 6 months
- Abnormal coagulation function
- History of psychotropic drug abuse or mental disorder
- Continuous glucocorticoid use within 1 month (except topical)
- Participation in other clinical studies within 6 months
- Any condition judged by investigator to endanger health or affect study results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The affiliated hospital of Qingdao university
Qingdao, Shandong, China
Actively Recruiting
Research Team
Y
Yun Lu
CONTACT
Y
Yuan Gao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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