Actively Recruiting
A Study to Evaluate the Efficacy and Safety of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma Who Have Failed Prior Therapy
Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2024-02-07
70
Participants Needed
44
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ICP-192, an oral drug, in a phase 2 clinical trial for patients with FGFR2-rearranged unresectable or metastatic intrahepatic cholangiocarcinoma who have not responded to prior therapies. This single-arm, open-label, multi-center study aims to assess the drug's effectiveness and safety in this specific patient group. The study is sponsored by Beijing InnoCare Pharma Tech Co., Ltd. and focuses on a serious form of liver cancer that has progressed after chemotherapy. Participants will receive ICP-192 as a 5 mg oral tablet. The study does not include a comparison group and involves administration of the drug over a period of up to three years. It includes continuous monitoring of treatment effects and safety throughout this time. The trial evaluates not only the tumor response but also various pharmacokinetic measures such as maximum concentration and half-life of the drug in the body. During the study, patients will undergo regular assessments including imaging to measure tumor size and progression, laboratory tests to monitor organ function and drug levels, and evaluation of any side effects using standardized criteria. The primary outcome is the objective response rate over up to three years, with secondary outcomes including survival, disease control, and duration of response. Safety will be closely observed, and the total participation could last up to three years depending on the patient's response and tolerance to the treatment.
CONDITIONS
Brief Title
A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form and age 18 years or older, any sex
- ECOG performance status score of 0 or 1
- Life expectancy greater than 3 months
- Diagnosed with unresectable, recurrent, or metastatic intrahepatic cholangiocarcinoma with disease progression after at least one chemotherapy line
- Confirmed FGFR2 fusion or rearrangement by central laboratory
- At least one measurable tumor lesion per RECIST 1.1 at screening
- Organ functions meet protocol requirements
- Use of contraception as required by the protocol
You will not qualify if you...
- Presence of other active cancers requiring treatment
- Previous treatment with selective FGFR inhibitors or FGFR antibodies
- Treatment with biological products, radical radiotherapy, or investigational drugs within 4 weeks before first study dose
- Chemotherapy within 3 weeks before first study dose
- Known symptomatic brain metastases
- Unresolved Grade 2 or higher adverse events from prior cancer treatments at study start
- Uncontrolled cardiovascular or cerebrovascular diseases or relevant history
- Any unstable or uncontrolled systemic disease such as active infections, uncontrolled hypertension, or poorly controlled diabetes
- Active bleeding conditions like deep vein thrombosis or portal hypertension-related bleeding
- Wounds with active infection
- Major surgery within 4 weeks or minor surgery within 2 weeks before first study dose
- Corneal or retinal abnormalities increasing risk of eye toxicity
- History or evidence of extensive tissue calcification except limited exceptions
- Serious gastrointestinal disorders affecting drug intake or absorption
- Active infections with HBV, HCV, or HIV
- Pregnancy, breastfeeding, or plans for pregnancy within 6 months after last dose
- Recent or planned use of strong CYP3A inhibitors or inducers
- Allergy to any study drug components
- Any condition judged unsuitable for trial participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive ICP-192 tablets orally as the study drug.
Visits scheduled regularly during treatment
Trial Site Locations
Total: 44 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China, 230036
Not Yet Recruiting
2
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Not Yet Recruiting
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032
Not Yet Recruiting
4
Beijing Youan Hosptital,Capital Medical University
Beijing, Beijing Municipality, China, 100069
Not Yet Recruiting
5
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Not Yet Recruiting
6
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
7
Fujian Cancer Hospital
Fujian, Fujian, China, 350011
Not Yet Recruiting
8
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Not Yet Recruiting
9
Mengchao hepatobiliary Hospital of FuJian Medical university
Fuzhou, Fujian, China, 350025
Not Yet Recruiting
10
Foshan First People's Hospital
Foshan, Guangdong, China, 528000
Not Yet Recruiting
11
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
12
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
13
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280
Actively Recruiting
14
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China, 050011
Not Yet Recruiting
15
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
16
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
17
First Affiliated Hospital of Zhengzhou University.
Zhengzhou, Henan, China, 450066
Not Yet Recruiting
18
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430062
Not Yet Recruiting
19
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Not Yet Recruiting
20
Human Provincial People's Hospital
Changsha, Hunan, China, 410002
Not Yet Recruiting
21
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
22
The Third Xiangya Hospital of Central South Uninversity
Changsha, Hunan, China, 410013
Not Yet Recruiting
23
Changzhou Tumor Hospital
Changzhou, Jiangsu, China, 213000
Not Yet Recruiting
24
Jiangyin Renmin Hospital
Jiangyin, Jiangsu, China, 214499
Not Yet Recruiting
25
The Affiliated Hospital of Nanjing University Meidical School
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
26
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215004
Not Yet Recruiting
27
Xuzhou Central Hospital
Xuzhou, Jiangsu, China, 221009
Not Yet Recruiting
28
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330000
Not Yet Recruiting
29
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Not Yet Recruiting
30
Liaoning Cancer Hospital&Institute
Shenyang, Liaoning, China, 110042
Not Yet Recruiting
31
Jiangxi Cancer Hospital
Nanchang, Nanchang, China, 330029
Not Yet Recruiting
32
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China, 750004
Not Yet Recruiting
33
Tangdu Hospital of the Fourth Military Medical University
Xi'an, Shaanxi, China, 710038
Not Yet Recruiting
34
Qilu Hospital
Jinan, Shandong, China, 250012
Actively Recruiting
35
Jinan Central Hospital
Jinan, Shandong, China, 250013
Actively Recruiting
36
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Not Yet Recruiting
37
ZhongShan Hospital
Shanghai, Shanghai Municipality, China, 200123
Not Yet Recruiting
38
The Third Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, China, 200433
Not Yet Recruiting
39
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
40
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
41
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
42
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310005
Not Yet Recruiting
43
Shulan（Hangzhou） Hospital
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
44
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
Research Team
J
Jin Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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