Total Neoadjuvant Treatment ±Immunotherapy for High Risk Locally Advanced Rectal Cancer (TNTi)

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT06229041
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The goal of this clinical trial is to compare the PCR rate between Total Neoadjuvant Treatment ±Immunotherapy in high risk locally advanced rectal cancer. The main questions it aims to answer are: * The PCR rate between the two groups * The 3years DFS between the two groups * Chemoradiotherapy and immunotherapy toxicity * Postoperative complications Participants will receive total neoadjuvant treatment ±immunotherapy followed by surgery. Researchers will compare neoadjuvant treatment ±immunotherapy to see the PCR rate.

Key Dates

Start date
Mar 29, 2023
Status verified
Jan 2024
Primary completion
Oct 1, 2027
Completion
Oct 1, 2029

Study Design

Enrollment
472 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Total Neoadjuvant Treatment ＋Immunotherapy
  • No Intervention: Total Neoadjuvant Treatment

Primary Outcome Measure

The PCR rate between total neoadjuvant treatment ±immunotherapy [ Time Frame: 2 years ]

Central Contacts

Related Studies