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SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR/MSS RC

ConditionsRectal AdenocarcinomaHigh-Risk CancerMSS
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSixth Affiliated Hospital, Sun Yat-sen University

About this trial

To explore the efficacy and safety of an intensified treatment regimen consisting of short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with precise targeted therapy (based on RAS/BRAF status: cetuximab for wild-type, bevacizumab for mutant) and a PD-1 monoclonal antibody, compared with short-course radiotherapy followed by mFOLFOX6 chemotherapy alone, in high-risk locally advanced pMMR/MSS rectal adenocarcinoma through a prospective, randomized controlled phase III clinical study, providing high-level evidence-based medical evidence to establish a superior neoadjuvant treatment strategy for this population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Before conducting procedures related to the research protocol but not part of routine care, written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulations and institutional guidelines.

Age 18-75 years.

Histologically or cytologically confirmed pMMR/MSS rectal adenocarcinoma; all other histological types are excluded.

Distance from the lower margin of the rectal tumor to the anal verge ≤10 cm.

Disqualifiers

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

Patients who have participated in or are currently participating in other clinical trials within 4 weeks prior to enrollment;

A history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy;

Severe electrolyte abnormalities;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Short-Course Radiotherapy

    Radiation

    Patients undergo SCRT at a dose of 5Gy × 5 fractions

  • PD-1 monoclonal antibody

    Drug

    Patients complete immune therapy with PD-1 monoclonal antibody for 4 cycles.

  • mFOLFOX6 regimen

    Drug

    Patients complete chemotherapy with mFOLFOX6 regimen for 4 cycles.

  • Cetuximab

    Drug

    Patients with RAS/BRAF wild-type receive targeting therapy with Cetuximab for 4 cycles.

  • Bevacizumab

    Drug

    Patients with RAS/BRAF mutations receive targeting therapy with Bevacizumab for 3 cycles. (Bevacizumab is not used in the last cycle of the bevacizumab group)

  • Surgical resection

    Procedure/Surgery

    Surgery either local excition or total mesorectal excision is performed 8-10 weeks after the completion of short-course radiotherapy.

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: SCRT + mFOLFOX6 + PD-1 Antibody + Targeted TherapyExperimental treatment 6 interventions
Group B: SCRT + mFOLFOX6Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

3 years DFS Rate

3 years Disease Free Survival Rate

Time frame
3 years

Secondary outcomes

1

pCR rate

pathological complete response rate

Time frame
1 year
2

3 years OS rate

3 years Overall Survival Rate

Time frame
3 years
3

3 years DMFS Rate

3 years Disease Metastasis Free Survival Rate

Time frame
3 years
4

3 years RFS Rate

3 years Recurrence Free Survival Rate

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

Source ClinicalTrials.gov
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