A Multicenter Trial of YSQTG vs. Simulated Agents With Neoadjuvant Chemoradiotherapy or Chemoimmunotherapy for EC

Summary

Esophageal cancer is a high - incidence cancer type in China, characterized by high incidence, high mortality, and low survival rates. Over 90% of esophageal cancer cases in China are squamous cell carcinoma, while in Western countries, approximately 80% are adenocarcinomas. Current international guidelines, including those of the NCCN and CSCO, are not entirely suitable for the diagnosis and treatment of esophageal cancer in the Chinese context. In recent years, although the 5 - year survival rate for esophageal cancer has improved, significant challenges remain, such as severe side effects during chemoradiotherapy and targeted - immunotherapy, decreased patient tolerance and quality of life, and even interruption of treatment.

To leverage the synergistic role of traditional Chinese medicine (TCM) in the treatment of major diseases, this study, which builds on previous research, is founded on the theory of "reinforcing healthy qi to strengthen the body, removing toxins, and resolving stasis." It aims to conduct a multicenter, randomized, controlled clinical trial of the TCM formula Yishen Qutong Granules, designed to reinforce healthy qi to strengthen the body and remove toxins, in combination with neoadjuvant concurrent therapy for locally advanced esophageal squamous cell carcinoma. The study will enroll 268 patients (1:1 ratio) with locally advanced esophageal squamous cell carcinoma (cTNM stage III - IVa) who are expected to undergo neoadjuvant concurrent therapy and are potentially resectable. On the basis of conventional Western medical treatment, the treatment group will be administered the patented TCM formula Yishen Qutong Granules orally, while the control group will receive a Yishen Qutong Simulated Granules orally.

The primary outcome measure will be the clinical benefit rate (CBR, CBR = CR + PR + SD), with secondary outcomes including pathological response rate (mPR), R0 resection rate, and TCM syndrome symptom score. The study aims to establish an objective evaluation system for the efficacy and safety of combined treatment based on the integration of disease and syndrome differentiation. It will also elucidate the mechanisms underlying the therapeutic effects of Yishen Qutong Granules.

Conditions

• Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

DRUG

Yishen Qutong Granules

The patent prescription of Professor Feng Li, the head of the Department of Traditional Chinese Medicine at the Cancer Hospital of the Chinese Academy of Medical Sciences.

DRUG

Yishen Qutong Simulant Granules

Yishen Qutong Simulant Granules is a preparation with one-tenth the dosage of Yishen Qutong Granules.

Sponsors & Collaborators

• China-Japan Friendship Hospital

  collaborator OTHER

• Shaanxi Provincial Cancer Hospital

  collaborator OTHER

• Changzhi People's Hospital

  collaborator OTHER

• Yuncheng Central Hospital

  collaborator OTHER

• Jilin Provincial Tumor Hospital

  collaborator OTHER

• Liaoning Cancer Hospital & Institute

  collaborator OTHER

• Shanghai Chest Hospital

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Wuhan No.1 Hospital

  collaborator OTHER

• Anyang Tumor Hospital

  collaborator OTHER

• Chongqing University Cancer Hospital

  collaborator OTHER

• Mianyang Central Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Sichuan Cancer Hospital and Research Institute

  collaborator OTHER

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  lead OTHER

Principal Investigators

• Li Feng, Ph.D. · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-22

Primary Completion

2025-10-31

Completion

2027-10-31

Countries

• China

Study Locations