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)

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

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorSixth Affiliated Hospital, Sun Yat-sen University

About this trial

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.

Eligibility criteria

Qualifiers

Before implementing any procedures related to the study protocol rather than routine clinical care, a signed and dated informed consent form must be obtained from the subject voluntarily, in accordance with regulatory requirements and institutional guidelines.

Age 18-75 years.

Histologically or cytologically confirmed pMMR/MSS rectal adenocarcinoma.

The lower edge of the rectal tumor is located below the peritoneal reflection.

Disqualifiers

Patients with a history of severe drug allergy (including allergy to platinum agents, 5-FU, and 5-HT3 receptor antagonists).

Patients who have participated in or are currently participating in another clinical trial within 4 weeks prior to enrollment.

History of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or any other therapy specifically targeting T-cell co-stimulation or checkpoint pathways.

Severe electrolyte abnormalities.

Trial design

Treatments tested in this trial

Short-course Radiotherapy, SCRT
Toripalimab

Treatment groups

76 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Sixth Affiliated Hospital, Sun Yat-sen University

Lead sponsor

Junshi Biosciences

Collaborator

Source ClinicalTrials.gov