Clinical Research Directory

Chaigui Jieyu Qufa Decoction for CRF in Driver Gene-negative Lung Adenocarcinoma Trial

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Summary

The goal of this \[clinical trial\] is to \[evaluate whether Chaiyu Jieyu Qufa Decoction can improve cancer-related fatigue and assess its safety\] in \[patients aged 18-80 years with untreated lung adenocarcinoma complicated with cancer-related fatigue of liver depression and spleen deficiency syndrome, who are scheduled to receive first-line platinum plus pemetrexed combined with PD-1/PD-L1 therapy\]. The main question\[s\] it aims to answer \[is/are\]: \[Does Chaiyu Jieyu Qufa Decoction reduce the severity of cancer-related fatigue measured by the Brief Fatigue Inventory (BFI) in patients with lung adenocarcinoma receiving platinum+pemetrexed+PD-1/PD-L1 treatment\]? \[Does Chaiyu Jieyu Qufa Decoction improve traditional Chinese medicine syndrome scores, fatigue-related quality of life, general quality of life, anxiety and depression status, tumour objective response rate and progression-free survival, without increasing safety risks\]? If there is a comparison group: Researchers will compare \[patients receiving Chaiyu Jieyu Qufa Decoction plus standard anti-tumour therapy\] to \[patients receiving placebo simulation agent plus the same standard anti-tumour therapy\] to see if \[the active herbal intervention achieves better relief of cancer-related fatigue and related secondary endpoints with acceptable safety\]. Participants will Receive platinum plus pemetrexed combined with PD-1/PD-L1 immunotherapy as standard first-line anti-tumour treatment; Take either Chaiyu Jieyu Qufa Decoction or matching simulation agent orally, 200 mL twice daily for 21 days; Complete questionnaire assessments including BFI, FACIT-F, EORTC QLQ-C30 and HADS at scheduled time points; Undergo blood, urine and stool tests plus liver and kidney function tests for safety evaluation; Receive contrast-enhanced imaging examinations to evaluate tumour response at specified follow-up time points; Attend follow-up visits up to 333 days after study enrolment.

Official title: A Multicenter, Randomized, Double-blind, Parallel-controlled Clinical Trial of Chaigui Jieyu Qufa Decoction Versus Placebo in Cancer-related Fatigue of Driver Gene-negative Lung Adenocarcinoma

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