Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer(CONTROL-01)
Recruiting
Phase 2
Interventional Study
Rectal Cancer Patients
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 35 (estimated)
- Sponsor
- The Affiliated Hospital of Qingdao University · Other
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About This Trial
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 d…
Trial Locations
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Eligibility Criteria
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 per…