Clinical Trial of Qizhu Yuling Prescription in the Prevention and Treatment of Esophagus Cancer

Last updated: November 19, 2022
Sponsor: Jie Li
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Disorders

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT05626309
2022-1-4151
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of Qizhu Yuling prescription for postoperative esophagus cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Esophageal cancer without esophagogastric junction pT1-4aN + M0 (stage IIB-IVA)meeting the diagnostic criteria without recurrence or metastasis;
  1. Patients who have completed adjuvant therapy (including adjuvant radiotherapy,adjuvant chemotherapy, adjuvant chemotherapy + radiotherapy) within 6 months after R0resection for esophageal cancer;
  2. ECOG score 0-2;
  3. 18-75 years old;
  4. Expected survival ≥ 3 months;
  5. Subjects voluntarily signed informed consent.

Exclusion

Exclusion Criteria:

    1. Combined with primary tumor at other sites;
  1. Patients complicated with severe primary diseases of heart, cerebral vessels,liver, kidney and hematopoietic system;
  2. Patients with mental illness and mental and language disorders;
  3. Participation in other clinical trials within 3 months;
  4. Patients with known hypersensitivity or intolerance to study drug.

Study Design

Total Participants: 310
Study Start date:
October 01, 2022
Estimated Completion Date:
November 30, 2024

Study Description

This study include a multi-center, randomized, double-blind, placebo, parallel controlled clinical trial.The randomized clinical trial will enroll approximately 310 patients. Participants will be randomly divided into experimental (n=155) and placebo groups (n=155).Patients in the experimental group was treated with Qizhu Yuling prescription within 6 months after esophagus cancer R0. Patients in the control group will receive the placebo.The primary endpoint is 1-year DFS (Disease-free survival) rate after surgery, that refers to the proportion of patients who do not have recurrence, metastasis or death (from any cause) within 1 years after surgery. The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.

Connect with a study center

  • Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

    Beijing, Beijing 100010
    China

    Active - Recruiting

  • Wangjing Hospital, China Academy of Chinese Medical Sciences

    Beijing, Beijing 100102
    China

    Active - Recruiting

  • Xiyuan Hospital, China Academy of Chinese Medical Sciences

    Beijing, Beijing 100091
    China

    Active - Recruiting

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