Clinical trial NCT05626309: Clinical Trial of Qizhu Yuling Prescription in the Prevention and Treatment of Esophagus Cancer
Official title: Qizhu Yuling Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Esophagus Cancer：A Randomized, Double-blind, Controlled and Multi-center Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophagus Cancer
Keywords: Postoperative esophagus cancer
Qizhu Yuling prescription
Chinese Herbal Medicine
Randomized Controlled Trial
1-year disease-free survival rate
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 1. Esophageal cancer without esophagogastric junction pT1-4aN + M0 (stage IIB-IVA) meeting the diagnostic criteria without recurrence or metastasis;

  2. Patients who have completed adjuvant therapy (including adjuvant radiotherapy, adjuvant chemotherapy, adjuvant chemotherapy + radiotherapy) within 6 months after R0 resection for esophageal cancer;

  3. ECOG score 0-2;

  4. 18-75 years old;

  5. Expected survival ≥ 3 months;

  6. Subjects voluntarily signed informed consent.

Exclusion Criteria:

* 1. Combined with primary tumor at other sites;

  2. Patients complicated with severe primary diseases of heart, cerebral vessels, liver, kidney and hematopoietic system;

  3. Patients with mental illness and mental and language disorders;

  4. Participation in other clinical trials within 3 months;

  5. Patients with known hypersensitivity or intolerance to study drug.

Primary outcomes:
measure: 1-year disease-free survival rate
timeFrame: The day of surgery until the first year
Secondary outcomes:
measure: Disease-free survival
timeFrame: Randomization until disease recurrence, metastasis, death (from any cause) , or 36 months after surgery, whichever occurs first.
measure: Overall survival
timeFrame: Randomization until death (from any cause) or 36 months after surgery, whichever occurs first.
measure: Cumulative annual recurrence and metastasis rate for 1-3 years
timeFrame: The day of surgery until the once, second and third year.
measure: Cumulative annual survival rate for 1-3 years
timeFrame: The day of surgery until the once, second and third year.
measure: Indexes related to fat distribution
timeFrame: before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).
measure: Visceral Adiposity Index
timeFrame: before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).
measure: Tumor marker
timeFrame: before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).
measure: Tumor marker
timeFrame: before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).
measure: Tumor marker
timeFrame: before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).
measure: Tumor marker
timeFrame: before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).
measure: Peripheral blood inflammatory index LMR
timeFrame: before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).
measure: Peripheral blood inflammatory index LNR
timeFrame: before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).
measure: Prognostic nutritional index
timeFrame: before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).
measure: Quality of life of the patient (QLQ-QES18)
timeFrame: Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.
measure: Evaluation of the patient's symptoms (MDASI-TCM)
timeFrame: Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.
measure: Medication compliance
timeFrame: From randomization to the end of the sixth course of medication （up to 24 weeks）.
measure: Percentage of Participants With Adverse Events
timeFrame: aseline until disease progression, death, or assessed up to 36 months after surgery.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Xiyuan Hospital, China Academy of Chinese Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Wangjing Hospital, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
name: Jie Li, Professor
role: STUDY_DIRECTOR
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Yu Wu, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Wangjing Hospital, China Academy of Chinese Medical Sciences
name: Shijie Zhu, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Hospital of Traditional Chinese Medicine
name: Guowang Yang, Professor
role: PRINCIPAL_INVESTIGATOR
References: