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New treatment option for Rectal Cancer Patients
Official title Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer（CONTROL-01）
ClinicalTrials.gov ID: NCT06647680
What this study is testing
What is Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles?
Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles is an investigational medicine, being studied as a potential treatment for rectal cancer patients.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Qingdao, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Qingdao, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.