Actively Recruiting
JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma
Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2025-07-02
72
Participants Needed
12
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This open-label, multicenter phase II study was designed to evaluate the safety and efficacy of JS207 alone or in combination with JS007 as first-line treatment in subjects with advanced HCC. The subjects were all subjects with unresectable, locally advanced, recurrent, or metastatic HCC who had not received previous systemic therapy. Planned to enroll 43 to 72 subjects.The study was divided into two stages, dose exploration stage (3-12 cases) and random expansion stage (40-60 cases).After the dose exploration phase, a dose group was selected to enter the randomized expansion phase based on comprehensive discussion and evaluation of DLT, AE, dose adjustment, PK parameters and preliminary efficacy results in each dose group.
CONDITIONS
Official Title
JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate and sign a written informed consent form.
- Age 18 years or older, male or female.
- Patients with histologically or cytologically confirmed hepatocellular carcinoma or hepatic cirrhosis meeting AASLD criteria.
- HCC classified as Barcelona Clinic Liver Cancer stage B or C, or stage IIa/IIb or IIIa/IIIb as defined by 2024 guidelines, and unsuitable for surgery or local treatment.
- No prior systemic therapy for HCC; adjuvant or neoadjuvant small molecule anti-angiogenic drugs allowed if last dose was at least 90 days before study drug.
- At least one measurable lesion per RECIST v1.1 not previously treated or showing progression after local therapy.
- Child-Pugh liver function class A or B with score 7 or less, without history of hepatic encephalopathy.
- ECOG Performance Status of 0 or 1.
- Life expectancy of 12 weeks or more.
- Major organ function meeting study requirements without recent transfusion or hematopoietic stimulating factors within 14 days prior to screening.
- Females of childbearing potential and males with partners of childbearing potential must use effective contraception during trial and for 6 months after last dose; females must have negative serum HCG test within 7 days before study and not be lactating.
You will not qualify if you...
- Received major surgery, live vaccination, investigational drug treatment within 4 weeks before first dose, or palliative radiotherapy for bone/brain lesions within 2 weeks before first dose.
- Receiving chronic systemic corticosteroids over 10 mg prednisone daily or other immunosuppressants within 7 days before first dose.
- Hepatic tumor burden exceeding 50% of total liver volume at screening.
- Cancer invasion of the portal vein main trunk (Vp4) involving more than half the lumen.
- Metastases to the central nervous system.
- Unresolved toxicity from prior treatments greater than grade 1 (except alopecia and peripheral neuropathy).
- Severe infection during screening, including recent hospitalization, prolonged antibiotic use, fever over 38.5°C, or high white blood cell count.
- Uncontrolled pericardial, pleural, or moderate/severe peritoneal effusion.
- Grade 3 or higher gastrointestinal or non-gastrointestinal fistula.
- Severe unhealed wounds, active ulcers, or untreated fractures.
- Severe cardiovascular disease.
- Recent digestive tract bleeding or significant bleeding disorders.
- History or signs of gastrointestinal obstruction within 6 months unless surgically treated.
- Active autoimmune disorders requiring systemic treatment within 2 years (replacement therapies allowed).
- Other malignancies within 5 years except certain cured localized tumors.
- History of interstitial lung disease or noninfectious pneumonitis except from local radiotherapy.
- Active tuberculosis or recent anti-tuberculosis therapy within one year.
- HBV or HCV infection with high viral loads or co-infection.
- Known HIV infection, prior stem cell or organ transplant, or immunodeficiency.
- Known severe allergy to monoclonal antibodies.
- Other conditions or factors that may affect study results or patient safety as assessed by the investigator.
AI-Screening
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Trial Site Locations
Total: 12 locations
1
The First Affiliated Hospital of USTC
Hefei, Anhui, China, 230022
Actively Recruiting
2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005
Actively Recruiting
3
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Not Yet Recruiting
4
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
5
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 451191
Not Yet Recruiting
6
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
7
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
8
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
9
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110801
Not Yet Recruiting
10
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 130061
Actively Recruiting
11
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine City:Shanghai
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
12
Shanghai East Hospital,School of Medicine, Tongji University
Shanghai, Shanghai Municipality, China, 200120
Not Yet Recruiting
Research Team
J
Jiazheng Yan, Master
CONTACT
F
Feng Li, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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