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A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequential PD-1 Inhibitor and FOLFOX Chemotherapy Versus Long-Course Chemoradiotherapy for High-Risk Locally Advanced pMMR/MSS Lower Rectal Adenocarcinoma (STAR Trial)

NCT07669220 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-06-25

No results posted yet for this study

Summary

This study adopts a prospective randomized controlled design to evaluate the efficacy and safety of short-course radiotherapy followed by sequential PD-1 inhibitor and FOLFOX chemotherapy versus conventional regimens in high-risk locally advanced pMMR/MSS lower rectal adenocarcinoma, aiming to provide high-level evidence supporting a novel treatment paradigm.

Conditions

  • Rectal Adenocarcinoma
  • High-risk Locally Advanced
  • Short-course Radiotherapy (SCRT)
  • Immunotherapy
  • FOLFOX

Interventions

RADIATION

Short-course Radiotherapy, SCRT

The neoadjuvant treatment phase includes either SCRT followed by 6 cycles of FOLFOX chemotherapy combined with a PD-1 inhibitor, or LCRT concurrent with 6 cycles of FOLFOX chemotherapy. Surgery is performed 2-4 weeks after the last cycle of chemotherapy. If reassessment indicates cCR and N0, options include Total Mesorectal Excision (TME), local excision (LE), or watch and wait (W\&W); otherwise, TME is performed. Postoperative adjuvant chemotherapy follows the CAPOX regimen.

DRUG

Toripalimab

The neoadjuvant treatment phase includes either SCRT followed by 6 cycles of FOLFOX chemotherapy combined with a PD-1 inhibitor, or LCRT concurrent with 6 cycles of FOLFOX chemotherapy. Surgery is performed 2-4 weeks after the last cycle of chemotherapy. If reassessment indicates cCR and N0, options include Total Mesorectal Excision (TME), local excision (LE), or watch and wait (W\&W); otherwise, TME is performed. Postoperative adjuvant chemotherapy follows the CAPOX regimen.

Sponsors & Collaborators

  • Junshi Biosciences

    collaborator UNKNOWN

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-01-01
Completion
2028-01-01

Countries

  • China

Study Locations

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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 NCT07669220 on ClinicalTrials.gov