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Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer

NCT06056804 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-02

No results posted yet for this study

Summary

This is an open, prospective, multi-center, single-arm phase II clinical study assessing the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin in patients with pMMR/MSS locally advanced middle and low rectal cancer.

Conditions

  • Locally Advanced Rectal Cancer

Interventions

DRUG

capecitabine

825-1000mg/m2,po,bid

DRUG

tislelizumab

200mg,iv.gtt,q3w

DRUG

thymalfasin

4.8mg,sc,biw

RADIATION

long-term radiotherapy

50 Gy/25 f, 2 Gy/day

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Beijing Friendship Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-03
Primary Completion
2024-12-01
Completion
2027-07-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06056804 on ClinicalTrials.gov