Total Neoadjuvant Therapy With PD-1 for Locally Advcancer Rectal Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of University of Science and Technology of China

About this trial

Research Objective:To investigate the efficacy and safety of the "total neoadjuvant chemoradiotherapy combined with immunotherapy" regimen for the treatment of locally advanced rectal cancer with high-risk features for recurrence.

Study Design:A single-arm, multicenter clinical study.

Study Population: Patients with locally advanced rectal cancer presenting with high-risk features for local recurrence.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed rectal adenocarcinoma;

Mid-low rectal cancer, with the lower edge of the tumor located within 12 cm from the anal verge;

Magnetic resonance imaging (MRI) suggests locally advanced rectal cancer (T3 or T4 and M0), accompanied by at least one of the following risk factors: cT4, N2, lymphovascular invasion, involvement of the mesorectal fascia, or enlarged lateral lymph nodes (short-axis diameter > 8 mm); patients with potentially resectable disease;

Polymerase chain reaction (PCR) testing indicates microsatellite stability (MSS) type;

Disqualifiers

Recurrent rectal cancer;

Synchronous colorectal cancer;

Pregnant or lactating patients;

History of other malignant tumors;

Trial design

Design model

Single group

Treatments tested in this trial

  • PD-1

    Drug

    patients will receive short-course chemotherapy and concurrent PD-1

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: TNT-immunityExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

pathological complete response rate

the incidence of no tumor residual after the treatment

Time frame
up to 2 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: