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A randomized, controlled, double-blind study of Fuzheng Jiedu granules in combination with icotinib in the first-line treatment of EGFR-sensitive mutated advanced lung adenocarcinoma

A randomized, controlled, double-blind study of fuzhengjiedu granules in combination with icotinib in the first-line treatment of EGFR-sensitive mutated advanced lung adenocarcinoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003632
Enrollment
Unknown
Registered
2020-08-22
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced adenocarcinoma lung cancer

Interventions

Sponsors

Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Those who meet the diagnostic criteria for primary bronchopulmonary carcinoma, histologically or cytologically confirmed as adenocarcinoma, with EGFR 21 exon L858R and EGFR 19 exon deletion mutations identified by Arm method or second generation sequencing. (2) Patients with non-surgical carriers of stage IIIB-IV NSCLC according to international staging criteria, or patients with carriers who have undergone surgery but have not undergone radical resection, or patients with recurrent postoperative metastases with objectively assessable tumor foci. (3) Aged between 18 and 80 years at the time of diagnosis of primary bronchopulmonary cancer. (4) After 1 month of taking icotinib, for patients whose TCM diagnosis belongs to Qi deficiency or Qi and Yin deficiency, the clinical diagnosis shall be confirmed by two or more attending physicians respectively. (5) Have not received any prior systemic treatment. (6) Survival is expected to be >= 6 months. (7) Physical condition score ECOG PS = 1.5x10^9/L, platelet>=80x10^9/L, no obvious abnormalities in liver and kidney function. (9) Willingness to accept the pilot programme and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Lack of objective evaluation of the tumour foci. (2) Those with an acute infection that has not been controlled, or with septic and chronic infections that have persistent wounds. (3) Persons who have used antipyretic or adrenocorticosteroid medications within 1 week, or who have taken oral pain medications containing NSAIDs for long-term pain control. (4) Refusal to accept this trial protocol. (5) Patients with symptomatic brain metastases.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Secondary

MeasureTime frame
PS;Quality of life scale score;immune function;TCM clinical symptom score;Adverse reactions;

Countries

China

Contacts

Public ContactShen Liping

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

slp252013@163.com+86 13524581252

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026