PG2 Concurrent With Chemoradiation for Locally Advanced Esophageal Cancer

NCT03611712 | Completed Phase 2

• 1 other identifier: PH-CP028
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 4

Brief Summary

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

Cancer-related Fatigue; Survival; Tumor, Esophageal

Keywords

Cancer-related Fatigue; Tumor response; Survival; Chemoradiation; esophageal cancer

Outcome Measures

Primary Outcomes (1)

• Fatigue by the Brief Fatigue Inventory-Taiwanese Form

  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.

  Through 12 weeks

Secondary Outcomes (6)

• Quality of life by the Functional Assessment of Cancer Therapy-General (FACT-G7 v.4)

  Through 12 weeks

• Visual Analog Score for appetite

  Through 12 weeks

• Tumor response be evaluated by RECIST 1.1, irRECIST and Pathological response.

  Week 11 and Week 12

• Disease free survival

  2 years after the take-off day of the last patient

• Overall survival in locally advanced esophageal cancer patients with PG2 treatment under preoperative chemoradiation therapy

  2 years after the take-off day of the last patient

Study Arms (2)

CCRT-PG2 arm

EXPERIMENTAL

Astragalus Polysaccharides 500 mg

Drug: Astragalus Polysaccharides 500 mg

CCRT alone arm

NO INTERVENTION

Interventions

Astragalus Polysaccharides 500 mg DRUG

PG2 Lyo. Injection 500 mg will be given on 1 week before CCRT (Week 1, PG2 Lyo. Injection 500 mg, b.i.w), during CCRT (Week 2-6, PG2 Lyo. Injection 500 mg, t.i.w for 5 weeks), and after CCRT (Week 7-8, PG2 Lyo. Injection 500 mg, t.i.w for 2 weeks)

Also known as: PG2 Lyo. Injection 500 mg

CCRT-PG2 arm

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PhytoHealth Corporation: lead

Study Sites (4)

Mackay Memorial Hospital

Taipei, 104, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Far Eastern Memorial Hospital

Taipei, 220, Taiwan

Location

Taipei Medical University -Shung Ho Hospital

Taipei, 235, Taiwan

Location

MeSH Terms

Conditions

Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Wen-Chien WC Huang, MD, PhD

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 2, 2018
• Study Start: February 19, 2019
• Primary Completion: February 3, 2023
• Study Completion: March 5, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-06

Locations

TW (4)