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Table 2 Ongoing clinical trials on enhancing the effect of ICIs by TCM

From: Traditional Chinese medicine in the era of immune checkpoint inhibitor: theory, development, and future directions

Year-author

Registry number

Cancer type

TCM

Formulation

Intervention

Controlled

Sample size

Primary outcomes

RCT

 2019-Zhong Y

ChiCTR1900026300

Malignant tumors

Xianglian Wan

Compound prescription

ICIs + Xianglian Wan

ICIs + Xianglian Wan placebo

44/44

PFS and intestinal flora

 2020-Li X

ChiCTR2000040911

Lung cancer

Astragalus Polysaccharide

Monomer

Anti-PD-1(Carrelizumab) + apatinib mesylate + Astragalus polysaccharide injection

Anti-PD-1(carrelizumab) + apatinib mesylate

30/30

PFS

 2020-Yang J

ChiCTR2000036977

NSCLC

Yiqijiedu compound

Compound prescription

Anti-PD-1(Pembrolizumab) + Yijiedufang Compound

Anti-PD-1(pembrolizumab)

30/30

PFS and MST

 2021-Yang J

ChiCTR2100041920

NSCLC

Yiqijiedu compound

Compound prescription

Anti-PD-1 + Yijiedufang Compound

Anti-PD-1 + placebo

40/40

PFS and OS

 2021-Tian W

ChiCTR2100045870

HCC

Huaier Granules

Chinese patent medicine

Anti-PD-L1(atelizumab) + bevacizumab + Huaier Granules

Anti-PD-L1(atelizumab) + bevacizumab

90/90

Tumor size, AFP, and safety

 2021-Yan D

ChiCTR2100051276

NSCLC

Baicalin combination

Monomer

Anti-PD-1 + baicalin combination

Anti-PD-1

76/76

Tumor size

 2022-Wu W

ChiCTR2200055453

NSCLC

Fuzheng Kangai Granule

Compound prescription

Anti-PD-1 + Fuzheng Kangai Granule

Anti-PD-1 + placebo

30/30

PFS

 2022-Feng C

ChiCTR2200061279

NSCLC

Shenlingbaizhu Powder

Compound prescription

Anti-PD-1 + Shenlingbaizhu Powder

Anti-PD-1

88/88

PFS

 2022-Zhang H

NCT05378334

NSCLC

HuGuXiaoJiTang

Compound prescription

Anti-PD-1 + chemotherapy + HGXJT

Anti-PD-1 + chemotherapy

41/41

DCR

Single-arm study

 2021-Li P

ChiCTR2100049159

HCC

TCM

Compound prescription

Anti-PD-1(carrelizumab) + TCM

NA

50

PFS

 2021-Cui H

ChiCTR2100051747

LUSC

GegenQinlian Tablets

Compound prescription

Anti-PD-1 + GegenQinlian Tablets

NA

27

ORR and DCR

 2021-Cao Y

ChiCTR2100046431

Lung cancer

Gensing Polysaccharides

Compound prescription

ICIs + Gensing Polysaccharides

NA

45

ORR and DCR

 2022-Wang G

ChiCTR2200058126

Pancreatic cancer

Fuzi Lizhong Pill

Compound prescription

Anti-PD-1(carrelizumab) + albumin paclitaxel + apatinib ± Fuzi Lizhong Pill

NA

30

ORR

Observational study

 2020-Wang L

ChiCTR2000032287

NSCLC

Bushen Tiaoyuan Recipe

Compound prescription

Anti-PD-1 + chemotherapy + Bushen Tiaoyuan Recipe

Anti-PD-1 + chemotherapy + placebo

55/55

ORR, AEs, and cancer fatigue score

 2022-Zhang F

ChiCTR2200055330

Stomach Cancer

Wenyang Tongluo Recipe

Compound prescription

Anti-PD- 1(toripalimab) + Wenyang Tongluo Recipe + apatinib

Anti- PD-1(toripalimab) + apatinib

30/30

Tumor size and tumor marker

  1. TCM traditional Chinese medicine, RCT randomized clinical trial, ICIs immune checkpoint inhibitors, PFS progression-free survival, PD-1 programmed death-1, NSCLC none-small-cell lung cancer, MST median survival time, OS overall survival, HCC hepatocellular carcinoma, PD-L1 programmed cell death-ligand 1, AFP alpha-fetoprotein, DCR disease control rate, NA not available, LUSC lung squamous cell carcinoma, ORR objective response rate, AEs adverse events