Personalized Long-course Radiotherapy Plus Chemotherapy With or Without Immunotherapy for LARC: PALACE Study

Sponsor
West China Hospital
Study ID
NCT07020247
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Anal Function Preservation
  • Immunotherapy
  • Locally Advanced Rectal Cancer (LARC)
  • Radiotherapy
  • Total Neoadjuvant Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anti-PD-1 antibody drug named Serplulimab — DRUG
    Serplulimab
  • Radiotherapy — RADIATION
    Radiotherapy is delivered using intensity-modulated radiotherapy (IMRT/VMAT) at a dose of 50-50.4Gy/ 25-28f(1.8-2.0Gy/d, 5f/w). For patients in the experimental group who achieve partial remission (PR) or better during the induction phase, an additional local boost dose of 6Gy/3f(2.0Gy/d, 5f/w) is administered to the PGTV.(No PGTV dose was given in the control group). For the treatment of lymph node metastasis in the lateral pelvic wall outside the mesorectal area: no additional dose is required when surgery is feasible, a sequential boost dose of 15Gy/3f is added when the lymph nodes are not surgically resectable.
  • Chemotherapy — DRUG
    Capox

Study Details

The study is a multicenter, randomized controlled, phase III clinical study, and the purpose of the study is to explore the complete response rate (CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR) sustained for over one year) of patients with locally advanced rectal cancer(LARC) treated with personalized long-course radiotherapy plus chemotherapy with or without Serplulimab. A total of 184 patients were included in this study.

Key Dates

Start date
Nov 19, 2024
Status verified
Dec 2024
Primary completion
Jul 31, 2027
Completion
Jan 31, 2028

Study Design

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

Arms

  • Experimental: Total Neoadjuvant Chemoradiotherapy+Serplulimab
    The experimental group intervention consists of the following: 1. Induction Phase: Two cycles of CAPOX and serplulimab prior to radiotherapy. 2. Concurrent Chemoradiotherapy: Two cycles of CAPOX and serplulimab administered concurrently with radiotherapy. 3. Consolidation Phase: Two additional cycles of CAPOX and serplulimab, initiated 2-3 weeks after completing radiotherapy. Radiotherapy is delivered using intensity-modulated radiotherapy (IMRT/VMAT) at a dose of 50-50.4Gy/25-28f (1.8-2.0Gy/d, 5f/w). For patients in the experimental group who achieve partial remission (PR) or better during the induction phase, an additional local boost dose of 6Gy/3f (2.0Gy/d, 5f/w) is administered to the PGTV. Tumor response is assessed 3-4 weeks after completing consolidation chemotherapy. Based on the evaluation, a decision is made to proceed with either total mesorectal excision (TME) or a watchful waiting strategy.
  • Active Comparator: Total Neoadjuvant Chemoradiotherapy
    The control group intervention consists of the following: 1. Induction Phase: Two cycles of CAPOX prior to radiotherapy. 2. Concurrent Chemoradiotherapy: Two cycles of CAPOX administered concurrently with radiotherapy. 3. Consolidation Phase: Two additional cycles of CAPOX, initiated 2-3 weeks after completing radiotherapy. Radiotherapy is delivered using intensity-modulated radiotherapy (IMRT/VMAT) at a dose of 50-50.4Gy/25-28f (1.8-2.0Gy/d, 5f/w). Tumor response is assessed 3-4 weeks after completing consolidation chemotherapy. Based on the evaluation, a decision is made to proceed with either total mesorectal excision (TME) or a watchful waiting strategy.

Primary Outcome Measure

Complete response rate [ Time Frame: 1 year ]

Central Contacts

Related Studies