Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05914389

Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2023-08-08

100

Participants Needed

1

Research Sites

365 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to elucidate the regression effects of neoadjuvant chemotherapy combined with immunotherapy and adjuvant therapy in locally advanced MSS colon cancer.

CONDITIONS

Official Title

Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years old
  • Pathologically diagnosed MSS or pMMR-type colon adenocarcinoma
  • Tumor lower edge more than 12 cm from the anus and not directly palpable during rectal exam
  • Enhanced CT stage T3/4 or T1-4N+ without multiple primary tumors or distant metastasis
  • Life expectancy over 1 year
  • First diagnosis with no prior anti-tumor treatment and no chemotherapy contraindications
  • Able to understand and willing to provide written informed consent
Not Eligible

You will not qualify if you...

  • Refusal to participate in the study
  • Multifocal colorectal cancer
  • History of malignant tumors except basal cell carcinoma, papillary thyroid carcinoma, and in situ cancers
  • Inability to tolerate chemotherapy, including bone marrow suppression
  • Acute exacerbation of major organ diseases or severe acute infections, ASA score > 3
  • Mental disorders, illiteracy, or language barriers preventing study understanding
  • Tumor obstruction or high risk of obstruction, bleeding, or perforation
  • Peripheral sensory neuropathy preventing oxaliplatin chemotherapy
  • Pregnancy or lactation
  • Inability to undergo enhanced CT or requiring glucocorticoid therapy
  • Use of glucocorticoids for more than 3 days within 1 month before consent
  • Tumor lower border below sacrococcygeal promontory to pubic symphysis line on mid-sagittal CT or MRI
  • Other conditions deemed unsuitable by the researcher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

L

Li Jun, MD

CONTACT

J

Jiao Yurong

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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