Clinical trial · Interventional
Clinical Trial of Qizhu Yuling Prescription in the Prevention and Treatment of Esophagus Cancer
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
NCT05626309CI-TRIAL-00062331unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of Qizhu Yuling prescription for postoperative esophagus cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophagus Cancer | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Qizhu Yuling Prescription | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Qizhu Yuling Prescription
- description
- Qizhu Yuling Prescription
- interventionNames
- Drug: Qizhu Yuling Prescription
- type
- PLACEBO_COMPARATOR
- label
- Placebo Comparator
- description
- Simulation agent of Qizhu Yuling Prescription Group
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- 1-year disease-free survival rate
- timeFrame
- The day of surgery until the first year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDKong M, Xu B, Zhu G, Wang X, Kuang Z, Sun Q, Liu K, Wang Z, Zhang Y, Li J. Qizhu Yuling prescription in the prevention of postoperative metastasis and recurrence of esophagus cancer: study protocol for a randomized, double-blind, placebo-controlled, multicenter clinical trial. Front Oncol. 2025 Mar 26;15:1478390. doi: 10.3389/fonc.2025.1478390. eCollection 2025. PMID 40206581