Non-small cell lung cancer
Conditions
Interventions
Control Group:First-line chemotherapy combined with PD-1 inhibitor therapy
Experimental Group:First-line chemotherapy + PD-1 inhibitor therapy + Huisheng oral solution, 10ml tid po, for 4 cycles.
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patient age 18-75 years, gender; 2. Pathologically confirmed as non-small cell lung cancer, pathological stage III-IV (International Union Against Cancer (UICC) latest 8th edition lung cancer TNM staging, Appendix 1); 3. Patients undergoing first-line chemotherapy combined with PD-1 inhibitor treatment for initial chemotherapy, expected to receive at least 4 cycles of treatment; 4. Performance status (PS) score =2, cognitive function normal, able to independently complete questionnaires involved in the study, expected survival =6 months; 5. Not taking other similar Chinese medicine or not receiving other traditional Chinese medical treatment methods (anti-cancer, anti-fatigue, tonifying qi and blood, etc.); 6. Hematological, liver and kidney function and major organ function indicators meet chemotherapy requirements; 7. No significant dysphagia, able to orally administer study drugs smoothly; 8. Gene wild-type; 9. Informed and willing to participate in this clinical trial, signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with malignant tumors in other sites; 2. Patients who have undergone tumor resection; patients who have not received first-line chemotherapy; patients who have previously undergone tumor chemotherapy; 3. Patients receiving concurrent radiotherapy, targeted drugs (including anti-angiogenic targeted drugs), and immunotherapy other than PD-1 inhibitors; 4. Patients with other confirmed causes of fatigue (e.g., hypothyroidism, moderate to severe anemia, severe malnutrition, cachexia, etc.); 5. Patients currently taking prescription stimulants or other explicitly labeled anti-cancer or anti-fatigue medications/supplements; 6. Patients with brain metastasis, trauma, or a history of severe mental illness; 7. Patients diagnosed with genetic mutations must be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Cancer-related fatigue severity assessment;Quality of Life Assessment;Pneumonia associated with immune checkpoint inhibitors; | — |
Countries
China
Contacts
Public ContactWang Lixin
Shanghai Pulmonary Hospital
Outcome results
None listed