Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Patients in this group will receive neoadjuvant chemotherapy.

Patients in this group will receive neoadjuvant chemoradiation therapy.

Paclitaxel 175mg/m2 plus Cisplatin 75mg/m2, q21d, 2 cycles

Paclitaxel, Cisplatin

Paclitaxel 50mg/m2 plus Carboplatin AUC=2, q1w, 5 cycles; 41.4Gy, 1.8Gy/d\*23

neoadjuvant chemoradiation therapy

Haibo Sun

Multimodal treatment combining surgery with chemotherapy and/or radiotherapy is necessary to improve the chances of survival in patients with locally advanced thoracic esophageal cancer. However, there is no consensus about the neoadjuvant treatment for resectable locally advanced esophageal squamous cell carcinoma. The aim of current randomized controlled clinical trail is to investigate the impact of neoadjuvant chemotherapy plus surgery and neoadjuvant chemoradiation therapy plus surgery on overall survival for patients with resectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 456 patients with locally advanced esophageal squamous cell carcinoma in 3 years. Eligible patients will be randomized into neoadjuvant chemotherapy group (paclitaxel 175mg/m2 plus cisplatin 75mg/m2, q21d, 2 cycles) or neoadjuvant chemoradiation group (41.4Gy, 1.8Gy\*23d plus paclitaxel 50mg/m2 plus carboplatin AUC=2, q1w, 5 cycles). The primary endpoint is 5 year overall survival and the secondary endpoints include 5 year disease-free survival, adverse events, pathologic complete response, postoperative complications, quality of life. The biomarkers predicting the sensitivity of neoadjuvant therapy will be explored.

Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Cancer (HCHTOG1903)

Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized, Controlled Clinical Trial (HCHTOG1903)

Henan Cancer Hospital

Attending surgeon

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Neoplasm Metastasis

Breast Diseases

Skin Diseases

Neoplastic Processes

The subject is administered according to the clinical dosage and method of medication until disease progression occurs or the subject is unable to tolerate treatment.Subjects receiving routine diagnosis and treatment simultaneously.

Subjects receive routine diagnosis and treatment without taking Huaier granules.

Huaier Granule

Zhimin Shao, PhD

Liang Huang, PhD

Li Ma, PhD

Xin Ge, PhD

Jinhui Hu, PhD

Boni Ding, PhD

Jinpeng Chen, PhD

Deyuan Fu, PhD

Jie Wang, PhD

Baosan Han, PhD

Xiaojia Wang, PhD

Caiping Chen, PhD

Shuzheng Chen, PhD

Yuechu Dai, PhD

Zhimin Shao, Professor

This is a multicenter, open-label, randomized controlled, prospective clinical study to evaluate the efficacy and safety of Huaier Granules in patients with advanced breast cancer without visceral metastasis.

This study used a blank control design and included at least 384 subjects. The experimental group and control group were randomized in a 2:1 ratio (at least 256 subjects in the experimental group and at least 128 subjects in the control group). Patients in the experimental group were treated with Huaier Granules (10g/dose, 3 times/day), while undergoing routine diagnosis and treatment; The control group received routine diagnosis and treatment, but did not take Huaier granules until the subjects experienced disease progression or intolerance.

Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis

A Multicenter, Open-label, Randomized, Controlled, Prospective Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis

During the treatment process, the decrease rate of immune related cytokines（Such as IL-1 β， IL-2，IL-4，IL-5，IL-6，IL-8，IL-10，IL-12，IL-17，TNF- α， IFN- α， IFN- γ etc.） compared to the baseline period

The time from randomization to the first occurrence of disease progression or death from any cause. As long as the subject experiences either "disease progression" or "death" first, it reaches the endpoint of the study

The time from randomization to death (from any cause)

The percentage of patients with advanced breast cancer who achieved a complete response, partial response, or stable disease for at least six months after treatment

Proportion of patients whose breast cancer has shrunk to a predetermined volume and maintains a minimum time limit

Harmful reactions of Huaier granules that are unrelated to the purpose of the medication under normal usage and dosage

LinkDoc Technology (Beijing) Co. Ltd.

Huazhong University of Science and Technology

Fudan University

professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Cancer (HCHTOG1903)	NCT04138212	Esophageal Squa...	Paclitaxel, Cis... neoadjuvant che...	18 Years - 70 Years	Henan Cancer Hospital
Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis	NCT05860907	Breast Cancer S...	Huaier Granule	18 Years - 75 Years	Fudan University

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