An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer

Sponsor
Fudan University
Study ID
NCT04443543
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Capecitabine (Xeloda) Pharmacogenetic Test Reagents — DRUG
    CRT: 625mg/m2 bid Monday-Friday per week XELIRI: 1000mg/m2 bid d1-14
  • irinotecan — DRUG
    CRT:80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7) XELIRI: 200mg/m2 bid d1 FOLFIRINOX: 150mg/m2 d1
  • IMRT — RADIATION
    Pelvic Radiation: 50Gy/25Fx
  • Oxaliplatin — DRUG
    FOLFIRINOX: 85mg/m2 d1
  • 5Fluorouracil — DRUG
    FOLFIRINOX: 400mg/m2 iv d1bolus, 2400mg/m2 ivgtt 46h
  • Tislelizumab — DRUG
    200mg iv

Study Details

The study is designed to test the hypothesis that the clinical complete response (CCR) rate of patients with locally advanced rectal cancer (LARC) treated with neoadjuvant chemoradiotherapy will increase after an adaptive-design paradigm, as well as the rate of 2-year organ preservation, recurrence, quality of life, DFS and OS.

Key Dates

Start date
Jun 22, 2020
Status verified
Jun 2020
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
222 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Arm 1 includes patients with MSS/pMMR. In this arm, patients receive consolidation chemotherapy after neoadjuvant chemoradiation (nCRT). The chemotherapy regimens either XELIRI or FOLFIRINOX, and the cycles of chemotherapy depend on patient tumor responses. For patients who reach cCR will enter the "W\&W" cohort and omit radical surgery, while those without cCR will receive radical surgery.
  • Experimental: Arm 2
    Arm 2 includes patients with MSI-H/dMMR status. In this arm, patients receive consolidation immunotherapy of 3 cycles of tislelizumab after nCRT. For patients who reach cCR will enter the "W\&W" cohort and omit radical surgery, while those without cCR will receive radical surgery.

Primary Outcome Measure

clinical complete response rate [ Time Frame: two weeks after completion of CRT or consolidation chemotherapy. ]

Central Contacts

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