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

NCT06863831 | Enrolling By Invitation DMC

• 2 other identifiers: NCC43692023YFC3503200
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Traditional Chinese Medicine; Western Medicine

Outcome Measures

Primary Outcomes (2)

• clinical benefit rate (CBR)

  clinical benefit rate, CBR=(CR+PR+SD)

  Assessed after completion of neoadjuvant therapy (2-4 cycles) and post-surgery, typically within 2-5 months after enrollment.

• Symptom Score

  Assess the symptom scores of esophageal squamous cell carcinoma using a questionnaire. Esophageal Cancer Obstruction and Dysphagia Symptom Score: 0: No obstruction, does not affect eating at all 1. Very mild sensation of obstruction, does not affect eating 2. Mild obstruction, does not affect eating 3. Mild obstruction but occasionally increased sensation of obstruction, very mildly affects eating, does not affect intake of liquids 4. Mild obstruction, mildly affects eating 5. Mild obstruction but occasionally increased sensation of obstruction, affects eating, including liquids 6. Moderate obstruction, affects eating, including liquids 7. Moderate obstruction and occasionally increased sensation of obstruction, can only swallow liquids 8. Severe obstruction, can only consume very thin liquids 9. Severe obstruction, can only drink water 10. Complete obstruction

  Assessed at the end of each treatment cycle (each cycle is 28 days), up to 5 cycles.

Secondary Outcomes (10)

• mPR resection rate

  At the end of the surgery

• R0 resection rate

  At the end of the surgery

• QLQ-C30 scale point

  Assessed at the end of each treatment cycle (each cycle is 28 days), up to 5 cycles.

• The NRS degree of pain caused by radiation esophagitis

  Assessed at the end of each treatment cycle (each cycle is 28 days), up to 5 cycles.

• Evaluation of Syndrome and Symptom Points of Traditional Chinese Medicine

  Assessed at the end of each treatment cycle (each cycle is 28 days), up to 5 cycles.

Study Arms (4)

Chemoradiotherapy TCM Treatment Group

EXPERIMENTAL

On the basis of neoadjuvant concurrent chemoradiotherapy (primarily based on a combination of Paclitaxel/Albumin-bound Paclitaxel, Cisplatin, and Radiotherapy), 10g/bag of Yishen Qutong Granules, 1 sachet per time, Tid, the administration cycle is the same as that of neoadjuvant concurrent chemoradiotherapy

Drug: Yishen Qutong Granules

Chemoradiotherapy TCM Simulant Group

PLACEBO COMPARATOR

On the basis of neoadjuvant concurrent chemoradiotherapy (primarily based on a combination of Paclitaxel/Albumin-bound Paclitaxel, Cisplatin, and Radiotherapy), 10g/bag of Yishen Qutong Granules (Yishen Qutong Simulant Granules, 1/10 Yishen Qutong Granules), 1 sachet per time, Tid, the administration cycle is the same as that of neoadjuvant concurrent chemoradiotherapy

Drug: Yishen Qutong Simulant Granules

Chemoimmunotherapy TCM Treatment Group

EXPERIMENTAL

Neoadjuvant chemotherapy combined with immune drug therapy (primarily based on a combination of Karelizumab, a Platinum-based drug, and either Albumin-bound Paclitaxel or Paclitaxel) based on the use of Yishen Qutong Granules, 10g/dose, Tid treatment, synchronized with immunotherapy and chemotherapy

Drug: Yishen Qutong Granules

Chemoimmunotherapy TCM Simulant Group

PLACEBO COMPARATOR

Neoadjuvant chemotherapy combined with immune drug therapy (primarily based on a combination of Karelizumab, a Platinum-based drug, and either Albumin-bound Paclitaxel or Paclitaxel) based on the use of Yishen Qutong Simulant granules (1/10 Yishen Qutong Granules), 10g/dose, Tid treatment, used in tandem with immunotherapy, chemotherapy

Drug: Yishen Qutong Simulant Granules

Interventions

Yishen Qutong Granules DRUG

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.

Also known as: YSQTG

Chemoimmunotherapy TCM Treatment Group; Chemoradiotherapy TCM Treatment Group

Yishen Qutong Simulant Granules DRUG

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

Also known as: YSQTSG

Chemoimmunotherapy TCM Simulant Group; Chemoradiotherapy TCM Simulant Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients met the diagnostic criteria of expected resectable stage III-IVa esophageal cancer, and esophageal squamous cell carcinoma was confirmed by pathology. The diagnostic criteria refered to the guidelines for the diagnosis and treatment of esophageal cancer (2018 edition). Staging criteria: UICC/AJCC TNM staging system (8th edition, 2017) was used.
• patients had not received previous treatment and planned to receive neoadjuvant simultaneous radiotherapy (radiotherapy + platinum in combination with albumin-paclitaxel), or proposed neoadjuvant chemotherapy in combination with immunopharmaceuticals (Immunotherapy reference 2024 CSCO Esophageal Cancer Diagnosis and Treatment Guidelines + platinum in combination with albumin-paclitaxel)
• In accordance with the syndrome type of positive deficiency and toxin stasis (kidney deficiency and deficiency syndrome + blood stasis and toxin stagnation syndrome), that is, at least one main symptom + two secondary symptoms in each syndrome scale;
• Karnofsky Performance Scale (KPS) ≥70; (5)18 ≤ age ≤ 80 ;
• (6) Patients who agreeed to participate in this study and sign the informed consent form.

You may not qualify if:

• ①Yishen Qutong Granules Comparison Simulator Cooperative Neoadjuvant Synchronized Radiotherapy Group: those who have contraindications to radiotherapy such as esophageal fistula or those who are allergic to chemotherapeutic drugs; ②Yishen Qutong Granules Comparison Simulator Cooperative Neoadjuvant Chemotherapy Combined with Immunotherapy Drugs Group: those who have contraindications to chemotherapy and immunotherapy or those who are allergic to the drugs;
• patients with a history of other tumors, cardiovascular and cerebrovascular diseases, liver and kidney function damage, hematopoietic system diseases, and other serious diseases;
• patients with mental disorders;
• patients during pregnancy and lactation;
• patients allergic to traditional Chinese medicine used in this study.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• China-Japan Friendship Hospital: collaborator
• Shanxi Provincial Cancer Hospital: collaborator
• Changzhi People's Hospital: collaborator
• Yuncheng Central Hospital: collaborator
• Jilin Provincial Tumor Hospital: collaborator
• Liaoning Cancer Hospital & Institute: collaborator
• Shanghai Chest Hospital: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Zhejiang Cancer Hospital: collaborator
• Henan Cancer Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Wuhan No.1 Hospital: collaborator
• Anyang Tumor Hospital: collaborator
• Chongqing University Cancer Hospital: collaborator
• Mianyang Central Hospital: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• The First Hospital of Jilin University: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Sichuan Cancer Hospital and Research Institute: collaborator

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College

Beijing, Chaoyang, 100021, China

Location

Related Publications (16)

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MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Li Feng, Ph.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: March 7, 2025
• Study Start: August 22, 2024
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)