Yifei Sanjie Formula or Placebo With Anlotinib as Second-Line or Above Treatment for Metastatic Non-Small-Cell Lung Cancer - Study Protocol

Sep 24, 2026

Background: Anlotinib is used as a third-line therapy for advanced non-small-cell lung cancer (NSCLC) but offers limited benefit and notable toxicity, including diarrhea and acneiform rash. Traditional Chinese Medicine (TCM) is widely used in China, and Chinese herbal medicines may act as adjuvants to lower toxicity and improve efficacy. This protocol evaluates whether adding Yifei Sanjie formula (YFSJF) to anlotinib improves progression-free survival (PFS).

LanguageEnglish

CategoryHealthcare

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Pages8

Reading Time20 min

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Abstract

Background

Methods

Discussion

Trial Registration

Ethics and Dissemination

Keywords

Background

Yifei Sanjie Formula or Placebo With Anlotinib as Second-Line or Above Treatment for Metastatic Non-Small-Cell Lung Cancer: Study Protocol for a Double-Blind, Placebo-Controlled Randomized Pilot Study Integrative Cancer Therapies Volume 22: 1–8 © The Author(s) 2023 Article reuse guidelines: [sagepub.com/journals-permissions](sagepub.com/journals-permissions)[ ](sagepub.com/journals-permissions)[DOI: 10.1177/15347354221151147](DOI: 10.1177/15347354221151147)[ ](DOI: 10.1177/15347354221151147)[journals.sagepub.com/home/ict](journals.sagepub.com/home/ict) Wenmin Chen, MM 1*, Jietao Lin, MD2*, Ting Yang, MM 1, Zexin Zhang, MM 1, Lanting Tao, MD 1, Zhiwei Xiao, MD2, Hanrui Chen, MM2, Xiangjun Qi, MM 1, Lingling Sun, MD2, Yang Cao, MD2, and Lizhu Lin, MD2 Abstract Background: Anlotinib is used as a third-line treatment for advanced non-small-cell lung cancer (NSCLC), but has limited clinical benefits and several side effects, such as diarrhea and acneiform skin rash. Traditional Chinese Medicine (TCM) is commonly used to treat cancers in China. Chinese herbal medicines may have the potential as adjuvant therapies to reduce toxicity and improve the efficacy of treatments for NSCLC. Given the positive outcomes of basic research, we plan to evaluate whether the addition of the Chinese herbal medicine Yifei Sanjie formula (YFSJF) to anlotinib can improve the progression-free survival (PFS) of advanced NSCLC patients. Methods: A multicenter, randomized, double-blind, placebo-controlled parallelgroup controlled pilot trial will be performed. Forty eligible patients will be randomized in a ratio of 1:1 to the intervention (YFSJF+anlotinib) and control (placebo + anlotinib) groups. Participants will be advised to take 12mg/day of anlotinib on days 1 to 14 of each 21-day cycle. YFSJF or placebo will be administered (15 g twice daily) during each cycle until progression of disease (PD). The primary outcome will be progression-free survival (PFS), and the secondary outcomes will be overall survival (OS), the objective response rate (ORR), and patient-reported outcomes (PRO). Tumors will be assessed based on RECIST v. 1.1 after every 2 cycles of treatment. The M. D. Anderson Symptom Inventory-Lung Cancer (MDASI-LC) will be used to evaluate PRO at baseline and weekly thereafter until PD. Discussion: This will be the first trial to evaluate the effectiveness and safety of TCM combined with anlotinib for the treatment of NSCLC. The results of this randomized controlled trial will fill a gap in the research by showing whether YFSJF combined with anlotinib can improve PFS in NSCLC patients. Trial Registration: The study was registered on June 8th, 2021 on Chinese Clinical Registry; registration number ChiCTR2100047143. ([https://www.chictr.org.cn/index.aspx](https://www.chictr.org.cn/index.aspx)). Ethics and Dissemination: The Ethics Committee of the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine approved the study protocol (approval no.: K2020151, 2021/08/19). The study will also be supervised and managed by the Ethics Committee. Keywords NSCLC, TCM, anloinib, YFSJF, combination therapy Submitted July 15, 2022; revised November 6, 2022; accepted December 30, 2022 Background Lung cancer has the highest fatality rate among all cancers.1 Non-small-cell lung cancer (NSCLC) is the most common lung cancer type, accounting for 85% of all lung cancers.2 Advanced NSCLC cannot be managed surgically and requires platinum-containing dual drug chemotherapy or targeted therapy as the first-line treatment. Based on tumor biological mechanisms, an increasing number of treatments are being developed for advanced NSCLC, including angiogenesis inhibitors. Bevacizumab was the first angiogenesis inhibitor approved for patients with Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons AttributionNonCommercial 4.0 License ([https://creativecommons

FAQs

What is the study testing about Yifei Sanjie formula and anlotinib?

The trial evaluates whether adding the Chinese herbal medicine Yifei Sanjie formula (YFSJF) to anlotinib improves progression-free survival (PFS) in advanced NSCLC patients compared with placebo plus anlotinib.

How is the randomized, double-blind pilot trial designed?

A multicenter, randomized, double-blind, placebo-controlled parallel-group pilot trial will randomize 40 eligible patients 1:1 to YFSJF+anlotinib or placebo+anlotinib.

What outcomes and assessments does the protocol use?

Primary outcome is PFS, with secondary outcomes including overall survival (OS), objective response rate (ORR), and patient-reported outcomes (PRO). Tumors are assessed using RECIST v.1.1 after every 2 cycles, and PRO is evaluated with MDASI-LC at baseline and weekly until progression.

Sep 24, 2026

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