Clinical trial · Interventional
PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer
- 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 primary objective of this study is to evaluate the efficacy of PG2 concurrent with concurrent chemoradiation therapy (CCRT) for relieving fatigue among locally advanced esophageal cancer patients who are under preoperative chemoradiation therapy at curative setting. This study will be designed to compare the fatigue status between two study arms patients under CCRT. The secondary objective is to assess the efficacy of PG2 to improve the quality of life of patient during CCRT. Also, the investigators try to determine the effect of PG2 on tumor response post CCRT, disease free survival (DFS) and overall survival (OS) of patients by comparing the above outcome between the two study arms. The mechanism of immunomodulatory of PG2 and tumor response, DFS and OS for patients with esophageal cancer treated with preoperative CCRT concurrent with or without PG2 will be investigated in add-on study.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Fatigue | — | UNRESOLVED | — |
| Survival | — | UNRESOLVED | — |
| Tumor, Esophageal | Esophageal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Astragalus Polysaccharides 500 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CCRT-PG2 arm
- description
- Astragalus Polysaccharides 500 mg
- interventionNames
- Drug: Astragalus Polysaccharides 500 mg
- type
- NO_INTERVENTION
- label
- CCRT alone arm
Primary outcomes (1)
- measure
- Fatigue by the Brief Fatigue Inventory-Taiwanese Form
- timeFrame
- Through 12 weeks
- description
- The Brief Fatigue Inventory (BFI) has been shown to have good reliability of fatigue measurement. This instrument consists of a one-page fatigue assessment tool that contains nine items, each measuring the severity of fatigue on a 0-through-10 scale. The first three items assess current level of fatigue, and worst and usual fatigue in the preceding 24 hours. Six items assess the extent to which fatigue has interfered with different aspects of life, such as work or social relations, during the preceding 24 hours. The BFI score is calculated from the mean of completed items.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who signed the informed consent form; * The age of eligible patients should be 20-75 years old; * Performance status of ECOG 0-1 at time of screening; * Have Esophageal and esophagogastric junction cancer (non-cervical esophagus); * Have stage IIB-IIIB locally advanced carcinoma of esophagus; * Pathologically confirmed primary squamous cell carcinoma of the esophagus; * Patient must be willing and able to complete fatigue and quality of life questionnaires. Exclusion Criteria: * BFI \> 7 at time of screening; * Concomitant malignancy or prior invasive malignancy unless disease free for a minimum of 2 years; * Medical contraindications to esophagectomy; * Female patients are pregnant or breast-feeding; * Have inadequate bone marrow, liver, and renal function * Uncontrolled systemic disease * Regular steroid use as determined by investigators; * Patients take central nervous system stimulators such as Methylphenidate within 30 days before screening; * Patients have enrolled or have not yet completed other investigational drug trials within 30 days before screening. * BMI \< 16 * Nutrition status SGA rating C.
References
Publications (0)
Data not yet available