Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT03748485

Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis

Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2026-01-28

650

Participants Needed

1

Research Sites

608 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Adjuvant chemotherapy was unnecessary in pathological stage Ⅱ colorectal cancer following initial treatment of surgery without high risk factors of recurrences. The treatment efficacy of adjuvant chemotherapy for pT1-3N0M0 colorectal cancer following preoperational chemotherapy or chemoradiotherapy remains unclear. Part of clinical local advanced colorectal cancer(cTxN1-2M0), which turn out to be pT0-3N0M0 after preoperational chemotherapy or chemoradiotherapy, might not really need adjuvant chemotherapy due to the down-stage efficacy of the preoperational treatments, or the misleading by lymph nodes false-positive imaging diagnosis.

CONDITIONS

Official Title

Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preoperative clinical tumor stage III (TxN1-2M0) colorectal cancer
  • Pathologically confirmed colorectal adenocarcinoma by endoscopic biopsy
  • Postoperative pathological stage T0-3N0M0 without high-risk recurrence factors
  • Ability to understand and sign written informed consent
Not Eligible

You will not qualify if you...

  • History of other malignant tumors
  • Complications requiring emergency surgery (such as occlusion, sub-occlusion, massive hemorrhage, or abscesses)
  • Tumor extension making immediate liver R0 resection impossible
  • Non-resectable lymph node metastasis
  • American Society of Anesthesiologists (ASA) grade IV or higher and/or ECOG score 2 or higher
  • Physical or psychological dependence
  • Pregnant or breastfeeding women
  • Uncontrolled preoperative infection
  • Participation in other clinical trials within 4 weeks
  • Other clinical or laboratory conditions deemed unsuitable by investigators

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China, 510655

Actively Recruiting

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Research Team

J

Jianping Wang, MD/PHD

CONTACT

J

Jun Huang, MD/PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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