Actively Recruiting
Neoadjuvant Chemotherapy and Tislelizumab (PD-1 Inhibitor) for Locally Advanced Rectal Cancer: a Single-center, Prospective, Phase II Study
Led by The Affiliated Hospital of Qingdao University · Updated on 2026-03-06
35
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and early effectiveness of combining chemotherapy with the PD-1 inhibitor Tislelizumab for patients with locally advanced rectal cancer. This phase II, single-center study focuses on patients diagnosed with stage T3 or T4 rectal adenocarcinoma without distant metastases. The trial is designed to assess clinical and pathological complete responses after treatment and surgery. Participants will receive three cycles of a combination chemotherapy regimen (CAPOX: Oxaliplatin and Capecitabine) along with Tislelizumab over nine weeks prior to surgery. After treatment, there will be a two-week rest before surgery, followed by decisions on additional therapy based on postoperative pathology. Treatment may continue unless disease progresses, intolerable side effects occur, or consent is withdrawn. Safety follow-ups occur approximately 30 and 90 days after treatment, and survival follow-up continues every three months for three years. During the study, participants will undergo laboratory tests and medical evaluations at specified times. The key outcomes include measuring clinical complete response at eight weeks after chemotherapy and pathological complete response after surgery. Participants are expected to spend about four to six hours during pre-study, study, and end-of-study visits. Long-term follow-up every three months will monitor survival and overall health status for up to 36 months from enrollment.
CONDITIONS
Brief Title
Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer（CONTROL-01）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Negative pregnancy test and willing to use adequate contraception during the trial and for 8 weeks after last drug administration
- Adequate bone marrow function defined as: ANC 600 cells/mm3, Platelets 100,000 cells/mm3, Hemoglobin 8.0 g/dl
- Adequate hepatic function within 28 days before registration: total bilirubin ULN unless Gilbert's disease, AST and ALT 3 x ULN, negative Hepatitis B and C if AST/ALT elevated
- Adequate renal function within 28 days before randomization: serum creatinine 1.5 x ULN or creatinine clearance > 30 mL/min
You will not qualify if you...
- Age less than 18 years
- Pregnant or breastfeeding women
- Prior invasive malignancy unless disease free for at least three years
- Preoperative body temperature 38�b0C or infections requiring systemic therapy
- 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 use of glucocorticoids within 1 month except topical
- Participation in other clinical studies within 6 months
- Investigator judgment deeming participation unsafe or affecting results
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 9 weeks
Participants receive a combination of chemotherapy (Oxaliplatin and Capecitabine) and PD-1 inhibitor (Tislelizumab) for 3 cycles prior to surgery.
Visits during 3 cycles of treatment as scheduled by the study
Duration - 2 weeks
Participants rest for 2 weeks after completing treatment before undergoing surgery.
No visits during rest period
Duration - Surgery day plus immediate recovery period
Participants undergo surgery and immediate post-operative care as part of their treatment plan.
1 surgical visit plus immediate post-operative visits as needed
Duration - Approximately 3 months
Participants have safety follow-up assessments approximately 30 and 90 days after discontinuing study treatment.
2 visits (in-person) approximately 30 and 90 days post-treatment
Duration - Up to 36 months
Participants are followed approximately every three months for survival until death, withdrawal, or study completion, up to 36 months from enrollment.
Quarterly visits approximately every 3 months
Trial Site Locations
Total: 1 location
1
The affiliated hospital of Qingdao university
Qingdao, Shandong, China
Actively Recruiting
Research Team
Y
Yun Lu
Y
Yuan Gao
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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