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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)

ConditionsRectal AdenocarcinomaHigh-risk Locally AdvancedShort-course Radiotherapy (SCRT)ImmunotherapyFOLFOX
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Short-course Radiotherapy, SCRT

    Radiation

    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.

  • Toripalimab

    Drug

    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.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: SCRT-PD1-FOLFOXExperimental treatment 2 interventions
Group B: LCRT-FOLFOXActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

CCR

cCR+pCR

Time frame
3 years

Secondary outcomes

1

3-year RFS

Time frame
3 years
2

3-year DFS

Time frame
3 years
3

3-year OS

Time frame
3 years
4

3-year DMFS

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sixth Affiliated Hospital, Sun Yat-sen University

Lead sponsor

Junshi Biosciences

Collaborator

Source ClinicalTrials.gov
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