ITMCTR2022000017
Not yet recruiting
Phase 1
Clinical study on prevention and treatment of postoperative recurrence and metastasis of lung cancer with traditional Chinese medicine based on Registration Platform
Conditionson small cell lung cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- on small cell lung cancer
- Sponsor
- Guang'anmen Hospital, China Academy of Chinese Medical Sciences
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •? Postoperative patients with stage ii\-iiia NSCLC diagnosed by pathology or cytology;
- •? Patients without tumor after adjuvant therapy were enrolled within 1 month after adjuvant therapy;
- •? The adjuvant chemotherapy regimen is the cycle of scheme 4 specified in NCCN guidelines
- •? Age 18\-75 years old;
- •? Ecog0\-1 for physical condition score;
- •? Estimated survival period \= 6 months;
- •? The subjects had no dysfunction of major organs, normal blood routine, liver, kidney and heart functions, liver function: blood bilirubin \= 2\.0uln, blood alanine aminotransferase and glutamic oxaloacetic aminotransferase \= 5uln; Renal function: serum creatinine \= 2\.0uln, blood urea nitrogen \= 2\.0uln; Bone marrow reserve: WBC \= 3\.0 × 109/l, absolute value of neutrophils (ANC) \= 1\.5 × 109/l, PLT \= 80 × 109/l, hemoglobin (Hgb) \= 80g/l.
Exclusion Criteria
- •? Preoperative neoadjuvant chemotherapy;
- •? Adenocarcinoma ex19del/l858r (\+) patients
- •? In other clinical trials;
- •? Have a birth plan within one year and have been pregnant or breast\-feeding patients;
- •? Those who cannot cooperate with the follow\-up and are allergic to the study drug;
- •? Using immunotherapy or targeted therapy
- •? Any situation that may prevent the subjects from completing the follow\-up process, including but not limited to severe and uncontrollable organic diseases or infections, unstable angina pectoris, congestive heart failure, etc; Severe liver and kidney dysfunction (serum creatinine \= 1\.5 times ULN; ALT or AST \= 5 times ULN; bilirubin \= 1\.5 times ULN); Patients with nervous, mental disease or mental disorder accompanied by symptoms and difficult to control; The patients with central nervous metastasis whose condition is not controlled and who have obvious cranial hypertension or neuropsychiatric symptoms;
Outcomes
Primary Outcomes
Not specified
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