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

NCT07020247 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2025-06-13

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Anti-PD-1 antibody drug named Serplulimab

Serplulimab

RADIATION

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.(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.

DRUG

Chemotherapy

Capox

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-19
Primary Completion
2027-07-31
Completion
2028-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07020247 on ClinicalTrials.gov