Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
ID05555888

Study of PD-1 Antibody Immunotherapy Combined with Short-course Radiotherapy and Chemotherapy for Early Low Rectal Cancer A Prospective Phase II Trial Assessing Treatment Response and Safety

Led by Fudan University · Updated on 2025-01-15

34

Participants Needed

1

Research Sites

124 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The study evaluates the combination of immunotherapy of PD-1 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer. A total of 34 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the local excision(TEM) or total mesorectal excision (TME). The rate of complete response (cCR+pCR), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.

CONDITIONS

Official Title

The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  1. age 18-70 years old, female and male
  2. pathological confirmed adenocarcinoma
  3. clinical stage T1-3bN0, tumor maximum diameter less than 4cm
  4. the distance from anal verge less than 5 cm
  5. without distance metastases
  6. KPS >=70
  7. with good compliance
  8. microsatellite repair status is MSS/pMMR
  9. without previous anti-cancer therapy or immunotherapy
  10. signed the inform consent
Not Eligible

You will not qualify if you...

  1. pregnancy or breast-feeding women
  2. pathological confirmed signet ring cell carcinoma
  3. clinical stage T1N0 and can be resected locally
  4. history of other malignancies within 5 years
  5. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
  6. immunodeficiency disease or long-term using of immunosuppressive agents
  7. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
  8. DPD deficiency
  9. allergic to any component of the therapy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

Z

Zhen Zhang, M.D, PH.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Short-course radiotherapy combined with chemotherapy and PD-1 inhibitor in low-lying early rectal cancer: study protocol for a single-arm, multicentre, prospective, phase II trial (TORCH-E).

Yajie Chen, Yaqi Wang, Hui Zhang...

https://pubmed.ncbi.nlm.nih.gov/37802608