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

NCT07214142 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: FirstAHUSTCina
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rectal Cancer Patients

Outcome Measures

Primary Outcomes (1)

• pathological complete response rate

  the incidence of no tumor residual after the treatment

  up to 2 months

Study Arms (1)

TNT-immunity

EXPERIMENTAL

1

Drug: PD-1

Interventions

PD-1 DRUG

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

TNT-immunity

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• No prior antitumor therapy, such as chemotherapy, radiotherapy, immunotherapy, or targeted therapy;
• Age between 18 and 75 years;
• ECOG Performance Status (PS) score of 0-1;
• Laboratory test results: WBC ≥ 3.5 × 10\^9/L, Hb ≥ 100 g/L, PLT ≥ 100 × 10\^9/L; normal liver and kidney function;
• Absence of severe comorbidities, and ability to tolerate surgical treatment;
• The patient or their immediate family member voluntarily agrees to participate in this study and provides written informed consent.

You may not qualify if:

• Recurrent rectal cancer;
• Synchronous colorectal cancer;
• Pregnant or lactating patients;
• History of other malignant tumors;
• Previous antitumor therapy, including chemotherapy or radiotherapy;
• Dysfunction of vital organs such as cardiac or pulmonary insufficiency;
• History of autoimmune diseases or immunodeficiency disorders;
• Use of immunosuppressive drugs within the past year;
• Distant metastasis to organs such as the abdominal cavity, pelvis, liver, or lungs;
• Active bleeding;
• Tumor involvement of adjacent structures such as the prostate or sacral organs, making the tumor unresectable;
• Allergy to chemotherapeutic agents, immune checkpoint inhibitors, or cetuximab;
• Psychiatric disorders or lack of capacity for civil conduct, unable to provide informed consent.

Sponsors & Collaborators

• The First Affiliated Hospital of University of Science and Technology of China: lead

Central Study Contacts

Liu Liu, MD

CONTACT

+86 15056017712; zhangxubing26240@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 9, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share