esophagus cancer
Conditions
Interventions
Chemoradiotherapy herbal medicine group:On the basis of neoadjuvant concurrent chemoradiotherapy (radiotherapy 1.8-2 Gy, 5 times a week, 4-5 weeks
platinum combined with nab-paclitaxel-based drug therapy), 10g/bag of Yishen Qutong Granules, 1 sachet per time, Tid, the administration cycle is the same as that of neoadjuvant concurrent chemoradiot
Chemoradiotherapy Chinese Medicine Simulant Group:On the basis of neoadjuvant concurrent chemoradiotherapy, the simulated agent of Yishen Qutong Granules (1/10 Yishen Qutong Granules) was used for tre
Chemotherapy Immunization Herbal Group
:Neoadjuvant chemotherapy combined with immune drug therapy (karelizumab + platinum + albumin paclitaxel) based on the use of Yishen Qutong Granules, 10g/dose, Tid treatment, synchronized with immunot
Chemotherapy immunomimetic group:Neoadjuvant chemotherapy combined with immune drug therapy (karelizumab + platinum + albumin paclitaxel) based on the use of Yishen Qutong elimination simulant granule
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) 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. (2)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) (3) 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; (4) Karnofsky Performance Scale (KPS) =70; (5)18 = age = 80 ; (6) Patients who agreeed to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) ?Yishen 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; ?Yishen 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; (2) patients with a history of other tumors, cardiovascular and cerebrovascular diseases, liver and kidney function damage, hematopoietic system diseases, and other serious diseases; (3) patients with mental disorders; (4) patients during pregnancy and lactation; (5) patients allergic to traditional Chinese medicine used in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical benefit rate, CBR=(CR+PR+SD);Symptom score; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;mPR resection rate;QLQ-C30 scale point;The incidence and degree of pain caused by radiation esophagitis;Evaluation of Syndrome and Symptom Points of Traditional Chinese Medicine ;Progression free survival (PFS);pathological complete response rate;KPS score;Changes in the tongue and pulse; | — |
Countries
China
Contacts
Public ContactFeng Li
Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College
Outcome results
None listed