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Clinical Trials/ITMCTR2022000017
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

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional study
Sex
Male

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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