Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer(CONTROL-01)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Affiliated Hospital of Qingdao University

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 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 criteria

Qualifiers

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

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles

Treatment groups

35 Participants
are divided into 1 treatment group