Adjuvant role of traditional Chinese medicine in postoperative gastric cancer

Table 4 Planned and ongoing clinical studies of traditional Chinese medicine for the treatment of gastric cancer

TCM	Compounds/constituents	Condition	Intervention	Study design	Time frame	Phase	Status	Primary outcome	Secondary outcomes	NCT number
TCM collaborative model	Radix Pseudostellariae (12 g), Rhizoma Atractylodis Macrocephalae (12 g), Poria (30 g), Rhizome Pinelliae Preparata (9 g), green tangerine peel (4.5 g), Concha Ostreae (30 g), and Prunella vulgaris (9 g)	Stage IIIb and IIIc gastric cancer who undergo radical surgery for D2 lymphadenectomy	Adjuvant chemotherapy (oxaliplatin plus capecitabine or S-1; or docetaxel plus S-1; docetaxel plus oxaliplatin plus 5-FU) (n = 130) vs adjuvant chemotherapy + TCM formula + auricular acupressure and acupoint therapy (n = 130)	Prospective, multicenter, randomized, open-label trial	36 months	Phase 2, phase 3	Completed	3-year DFS rate	Quality of life, side effects caused by chemotherapy, and safety-related measures	NCT03607656
Yiqi Wenyang Jiedu prescription	Astragalus membranaceus (30 g), Codonopsis pilosula (15 g), Angelica dahurica (10 g), Curcuma zedoary (9 g), Rhizoma nardostachyos (10 g), Polygonum cuspidatum (10 g), Radix Actinidiae chinensis (15 g), and Paris polyphylla (9 g)	Completed adjuvant chemotherapy within 8 months of radical gastrectomy	YWJP (n = 106) vs YWJP placebo (n = 106)	Multicenter, randomized, double-blind, placebo-parallel-controlled clinical trial	24 weeks	Phase 4	Unknown	DFS rate 2 years after surgery	DFS time, overall survival, annual cumulative recurrence and rate of metastasis after 1-3 years, cumulative annual survival after 1-3 years, fat distribution-related indicators, tumor markers, peripheral blood inflammatory indicators, prognostic nutritional index, symptoms and quality of life evaluation, medication compliance, and adverse reaction rate	NCT05229809
Hou Gu Mi Xi (modified Shen Ling Bai Zhu San)	Ginseng, tuckahoe, baked licorice, coixenolide, Chinese yam, lotus seed, shrinkage fructus amomi, white hyacinth bean, dried orange peel, and perilla leaf	Spleen qi deficiency status in GC patients after radical gastrectomy	Dietary supplement: Hou Gu Mi Xi (n = 65) vs Other: Placebo (n = 65)	Multicenter, randomized, double-blinded, parallel-group, placebo-controlled trial	104 weeks	N/A	Terminated (high attrition rate)	Spleen Qi deficiency symptoms grading and quantifying scale	Quality of life assessed by the Short Form 36 scale, performance status as assessed by the Eastern Cooperative Oncology Group Performance Status scale, body weight, and body mass index	NCT03025152
Modified Banxia Xiexin decoction	N/A	Stage IV GC	Modified Banxia Xiexin decoction combined chemotherapy (n = 73) vs placebo granules combined chemotherapy (n = 73)	Randomized clinical trial	18 weeks	Early phase 1	Completed	Overall survival	Progression-free survival, solid tumor efficacy, TCM syndrome score, quality of life score, tumor markers, Immune function and adverse reactions	NCT05908838
Huaier granule	N/A	Patients with stage II or III gastric adenocarcinoma who undergo radical gastric adenocarcinoma within 2 months of surgery	Huaier granule (n = 351) vs SOX regimen (n = 351)	Prospective, multi-center, open-label, randomised controlled study	3 years	Phase 4	Not yet recruiting	3-year DFS rate	1-, 2-, 3-year OS rate, 1-, 2-, 3-year local recurrence-free survival rate, 1-, 2-, 3-year distant metastasis-free survival rate, quality of life score	NCT05498766
Weifichun	N/A	Gastric adenocarcinoma patients undergoing chemotherapy	Weifichun combined chemotherapy (n = 36) vs chemotherapy (n = 36)	Randomized clinical trial	24 weeks	Early phase 1	Completed	OS rate	Progression-free survival, EuroPean organization for Research and Treatment Quality of Life Scale, clinical symptoms, tumor markers, immune function	NCT05888675
Acupuncture	Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints	GC patients after R0 resection and D2 lymph node dissection	High-dose acupuncture + chemotherapy vs low-dose acupuncture + chemotherapy vs none-acupuncture	Randomized, open label, pilot study	3 cycles of adjuvant chemotherapy	N/A	Completed	FACT-gastric trial outcome index, C-ESAS	Incidence of treatment-emergent adverse events, adherence to chemotherapy, concentration of inflammatory factors in plasma, circulating myeloid-derived suppressor cells, circulating CD8+ T lymph cells, circulating tumor cells	NCT03753399
	N/A	POI after gastrectomy in patients with GC	Acupuncture vs none-acupuncture	Prospective randomized pilot study	5 postoperative days	N/A	Completed	Remnant sitz markers in small intestine	Time to first flatus, start of water intake, start of soft diet, hospital stay	NCT02480361
	For participants with abdominal distension: LI4, PC6, ST36, SP6. For participants with post-operative ileus: LI4, SJ6, ST36, ST37	Underwent abdominal surgery within one month	Electroacupuncture combined with metoclopramide vs metoclopramide	Non-randomized, parallel assignment	3 days	N/A	Unknown	Visual Analogue Scale, daily feeding volume, gastric residual volume	Acute Physiology and Chronic Health Evaluation II score, Sequential Organ Failure Assessment score, Physiological and operative severity scores for the enumeration of mortality and morbidity score, blood examination	NCT04467528
	Electroacupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu	Patients with gastric cancer who undergoing gastrectomy	Electroacupuncture vs Sham electroacupuncture	Randomized, parallel assignment	7 days	N/A	Unknown	Gastrointestinal function score	Physical fitness index	NCT03291574

N/A: Not applicable; YWJP: Yiqi Wenyang Jiedu prescription; DFS: Disease-free survival; OS: Overall survival; POI: Postoperative ileus; C-ESAS: Chinese version of edmonton symptom assessment scale; GC: Gastric cancer; 5-FU: 5-Fluorouracil; TCM: Traditional Chinese medicine; SOX: Sry-related HMG-box; FACT: Facilitates chromatin transcription.