Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT05862337

Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence.

Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2023-05-17

480

Participants Needed

67

Research Sites

185 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The primary objective of this study was to evaluate the efficacy of anlotinib hydrochloride capsules combined with penpulimab injection (test group) versus placebo (control group) for adjuvant therapy after radical surgery or ablation in HCC patients with high risk of recurrence by assessing recurrence-free survival (RFS).

CONDITIONS

Official Title

Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence.

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years old
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  • Predicted survival of at least 12 weeks
  • Diagnosis of hepatocellular carcinoma confirmed by histopathology, cytology, or established diagnostic criteria
  • Received radical surgery or radio frequency/microwave ablation within 4 to 12 weeks prior to randomization
  • No major portal vein invasion (Vp3 or Vp4) or vascular invasion in hepatic vein or inferior vena cava
  • No metastasis outside the liver
  • High risk factors for recurrence after surgery or ablation
  • Complete recovery from surgery or ablation at least 4 weeks before randomization
Not Eligible

You will not qualify if you...

  • Fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma and hepatocellular carcinoma histology
  • Evidence of residual, recurrent, or metastatic disease at randomization
  • More than one surgical treatment for hepatocellular carcinoma
  • More than one prophylactic Transcatheter Arterial Chemoembolization (TACE) after surgery
  • Received Hepatic Artery Infusion Chemotherapy (HAIC) after surgery
  • Previous use of antiangiogenic drugs
  • Previous use of PD-1, PD-L1, or related immunotherapy drugs
  • Previous systemic chemotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 67 locations

1

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China, 233000

Actively Recruiting

2

Anhui Provincial Hospital

Hefei, Anhui, China, 230000

Actively Recruiting

3

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 230000

Not Yet Recruiting

4

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100005

Actively Recruiting

5

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100020

Actively Recruiting

6

Peking University People's Hospital

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

7

Beijing Friendship hospital of Capital Medical University

Beijing, Beijing Municipality, China, 100050

Actively Recruiting

8

Beijing YouAn Hospital,Capital Medical University

Beijing, Beijing Municipality, China, 100069

Actively Recruiting

9

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China, 400030

Not Yet Recruiting

10

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, China, 404199

Not Yet Recruiting

11

Mengchao Hepatobiliary Hospital of Fujian Medical

Fuzhou, Fujian, China, 350001

Actively Recruiting

12

Fujian Cancer Hospital

Fuzhou, Fujian, China, 350011

Actively Recruiting

13

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China, 730000

Actively Recruiting

14

Lanzhou University First Hospital

Lanzhou, Gansu, China, 730000

Not Yet Recruiting

15

Lanzhou University Second Hospital

Lanzhou, Gansu, China, 730030

Not Yet Recruiting

16

Gansu Provincial Hospital

Lanzhou, Gansu, China, 730700

Actively Recruiting

17

Guangdong People's Hospital

Guangzhou, Guangdong, China, 510000

Not Yet Recruiting

18

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510280

Actively Recruiting

19

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China, 510630

Actively Recruiting

20

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, China, 530000

Not Yet Recruiting

21

Guizhou Provincial People'S Hospital

Guiyang, Guizhou, China, 550002

Actively Recruiting

22

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China, 550008

Not Yet Recruiting

23

Affiliated Hospital Of Zunyi Medical University

Zunyi, Guizhou, China, 563000

Actively Recruiting

24

Hainan Provincial People's Hospital

Haikou, Hainan, China, 570311

Actively Recruiting

25

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China, 570311

Actively Recruiting

26

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, China, 150081

Actively Recruiting

27

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China, 471000

Actively Recruiting

28

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450000

Actively Recruiting

29

Henan Cancer Hospital

Zhengzhou, Henan, China, 450003

Not Yet Recruiting

30

Hunan Cancer Hospital

Changsha, Hunan, China, 410000

Not Yet Recruiting

31

Hunan Provincial People's Hospital

Changsha, Hunan, China, 410000

Not Yet Recruiting

32

The Third Xiang Ya Hospital of Central South University

Changsha, Hunan, China, 410000

Actively Recruiting

33

Xiangya Hospital of Central South University

Changsha, Hunan, China, 410000

Not Yet Recruiting

34

Chifeng Municipal Hospital

Chifeng, Inner Mongolia, China, 240000

Actively Recruiting

35

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China, 213000

Actively Recruiting

36

Jiangsu Province People's Hospital

Nanjing, Jiangsu, China, 210000

Actively Recruiting

37

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China, 226006

Actively Recruiting

38

Nantong Tumor Hospital

Nantong, Jiangsu, China, 226361

Not Yet Recruiting

39

Ganzhou People's Hospital

Ganzhou, Jiangxi, China, 341099

Actively Recruiting

40

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330000

Actively Recruiting

41

Jilin Cancer Hospital

Changchun, Jilin, China, 130012

Not Yet Recruiting

42

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China, 116027

Actively Recruiting

43

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, China, 121012

Actively Recruiting

44

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China, 110000

Not Yet Recruiting

45

The Sixth People's Hospital of Shen Yang

Shenyang, Liaoning, China, 110000

Actively Recruiting

46

Liaoning Cancer Hospital

Shenyang, Liaoning, China, 110801

Not Yet Recruiting

47

Binzhou Medical University Hospital

Binzhou, Shandong, China, 256699

Actively Recruiting

48

Shandong Cancer Hospital

Jinan, Shandong, China, 250117

Not Yet Recruiting

49

The First Affiliated Hospital of Naval Medical University

Shanghai, Shanghai Municipality, China, 200433

Actively Recruiting

50

Third Affiliated Hospital of Naval Medical University

Shanghai, Shanghai Municipality, China, 200433

Actively Recruiting

51

Baoji Central Hospital

Baoji, Shanxi, China, 721000

Actively Recruiting

52

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China, 46000

Actively Recruiting

53

The Second Affiliated Hospital of Air Force Medical University

Xi’an, Shanxi, China, 710038

Not Yet Recruiting

54

First Affiliated Hospital of Xian Jiaotong University

Xi’an, Shanxi, China, 710061

Not Yet Recruiting

55

Xi'an International Medical Center Hospital

Xi’an, Shanxi, China, 710117

Actively Recruiting

56

West China Hospital of Sichuan University

Chengdu, Sichuan, China, 610000

Actively Recruiting

57

Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China, 646000

Actively Recruiting

58

Affiliated Hospital Of North Sichuan Medical College

Nanchong, Sichuan, China, 637000

Actively Recruiting

59

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, China, 300000

Actively Recruiting

60

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China, 300181

Actively Recruiting

61

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China, 300308

Actively Recruiting

62

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China, 830000

Not Yet Recruiting

63

Sir Run Run Shaw Hospital Zhetiang University School of Medicine

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

64

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China, 315000

Actively Recruiting

65

Shaoxing People's Hospital

Shaoxing, Zhejiang, China, 312000

Actively Recruiting

66

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China, 317000

Actively Recruiting

67

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China, 325000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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