Hepatocellular CarcinomaPhase 2NCT06954467
JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma
A Phase 2 study testing JS207 and JS007 in people with Hepatocellular Carcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 12 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- JS207 and JS007
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 12 sitesChina
- Study dates
- 29 May 2025to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to participate and sign a written informed consent form.
- Age ≥ 18 years, male or female.
- Patients with histologically/cytologically confirmed HCC or Hepatic cirrhosis meeting the criteria of the American Association for the Study of Liver Diseases (AASLD) can be enrolled.
- HCC classified as Barcelona Clinic Liver Cancer (BCLC) stage B (intermediate stage) or stage C (advanced stage), or stage IIa/IIb or IIIa/IIIb as defined by the Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition), prior to lymph node clearance, and deemed unsuitable for surgical and/or local treatment.
- No systemic therapy for HCC prior to study entry (mainly including systemic chemotherapy, targeted therapy, immunotherapy, etc.; adjuvant/neoadjuvant administration of small molecule anti-angiogenic drugs, such as lenvatinib, sorafenib, and donafenib, is allowed, but the last dose of these drugs must be administered ≥90 days prior to the first dose of the study drug).
- Having ≥1 measurable lesion according to RECIST v1.1. Requirement: The selected target lesion had not been subjected to local therapy previously, or the selected target lesion was located in the area of previous local therapy, but later determined to be progressed through imaging examination according to RECIST v1.1.
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- Child-Pugh liver function class A or B ≤ 7 without history of Hepatic encephalopathy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.
- Life expectancy ≥12 weeks.
- Major organ function meets the following requirements, without transfusion, hematopoietic stimulating factors (including G-CSF, GM-CSF, EPO and TPO, etc.) or human Albumin preparations within 14 days prior to screening:
- Females of childbearing potential and males whose partners are of childbearing age are required to use highly effective contraceptive measures during the trial and for at least 6 months after the last dose (Appendix 5). Female patients of childbearing potential must have a negative serum HCG test within 7 days before study entry and must be non-lactating.
Who cannot join
- Participants who meet any of the following criteria should be excluded from this study:
- Received major surgery (requiring general anesthesia and >24 hours of hospitalization, excluding diagnostic biopsy), live vaccination, or investigational drug treatment within 4 weeks prior to the first dose, or received palliative radiotherapy for localized bone/brain lesions within 2 weeks prior to the first dose.
- Patients who are receiving chronic systemic corticosteroid therapy (daily dose >10 mg prednisone or other glucocorticoid with the same effect) or other immunosuppression therapy within 7 days prior to the first dose.
- Hepatic tumor burden > 50% of total hepatic volume at screening.
- Invasion of portal vein main trunk (Vp4) by cancer thrombus (more than 1/2 of lumen) as confirmed by CT/MRI examination.
- Presence of metastases to central nervous system of HCC; MRI scan of brain and/or spine is required to rule out the possibility when it is suspected.
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- Toxicity induced by previous treatment (except for alopecia and Neuropathy peripheral) has not recovered to ≤ grade 1 (NCI-CTCAE v5.0).
- Severe infection during the screening period, including but not limited to hospitalization for infection, bacteraemia or severe pneumonia complications, oral or intravenous administration of therapeutic antibiotics for ≥7 days within 14 days prior to the first dose (patients receiving prophylactic antibiotics can be enrolled), fever ≥38.5°C of unknown origin within 7 days prior to the first dose or white blood cell count >15×109/L at baseline.
- Uncontrolled pericardial effusion, uncontrolled pleural effusion, or clinically evident moderate or severe peritoneal effusion during screening period is defined as meeting the following criteria: having clinical symptoms and detectable pericardial, pleural, and peritoneal effusion on physical examination; or pleural and peritoneal effusion requiring puncture and aspiration and/or intracavitary drug administration for treatment.
- Grade ≥3 (NCI-CTCAE v5.0) gastrointestinal or non-gastrointestinal fistula during screening period.
- Existence of severe unhealed wounds, active ulcer and Therapy naive fracture at screening period.
- Severe cardiovascular diseases.
- History of haemorrhage of digestive tract within 6 months prior to the first dose, or clear haemorrhagic diathesis (including high-risk severe esophageal-gastric varicose vein, local active digestive tract ulcer lesions, and persistent faecal occult blood positive; if faecal occult blood positive at baseline, it can be rechecked; if still positive after recheck, upper gastrointestinal endoscopy is required; if endoscopy indicates severe esophageal-gastric varicose vein or the investigator judges that there is a clear risk of bleeding, then the subject cannot be enrolled).
- Evidence of other haemorrhagic diathesis or significant coagulopathy.
- History of intestinal obstruction and/or clinical signs or symptoms of gastrointestinal tract obstruction within 6 months prior to the first dose, including incomplete obstruction associated with pre-existing diseases requiring routine parenteral hydration, parenteral nutrition, or enteral feeding (patients who received definite [surgical] treatment prior to the first dose to resolve the obstruction symptoms were allowed to be enrolled).
- Active autoimmune disorders requiring systemic treatment within 2 years prior to the first dose; however, replacement therapy (e.g., Thyroxine, Insulin, or physiological replacement of corticosteroids for adrenal or Pituitary insufficiency) will not be considered as systemic treatment and is allowed.
- Having had neoplasm malignant (except HCC) within 5 years prior to the first dose, including mixed type of liver cancer; however, localized tumors that have been cured, including Carcinoma cervix in situ, Basal cell carcinoma, and Carcinoma in situ of prostate, etc.
- History of interstitial lung disease or noninfectious pneumonitis, unless caused by local radiotherapy.
- Patients with active tuberculosis or who have received anti-tuberculosis therapy within one year prior to the first dose.
- HBV and/or HCV infection: a) HBsAg (+) and/or HBcAb (+), and HBV DNA > 1000 IU/mL (if the lower limit of the minimum measurable value of the local center is higher than 1000 IU/mL, enrollment will be decided according to the specific circumstances after discussion with the sponsor; the patient must continue to receive the original anti-HBV therapy throughout the study, or start the entecavir or tenofovir throughout the study after screening); b) positive HCV Antibody and HCV RNA > upper limit of normal; c) co-infection with hepatitis B and C.
- Known history of human immunodeficiency virus (HIV) infection, prior allogeneic stem cell or Solid organ transplant, or other Immunodeficiency.
- Known severe allergy to any Monoclonal antibodies.
- Other factors that may affect the study results or cause the study to be terminated prematurely, as judged by the investigator, such as alcoholism, Drug of Abuse, other serious diseases (including mental disorders), need for concomitant treatment, serious Laboratory test abnormal, and family or social factors that may affect the patient's safety.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Shunda Du, Doctor, +86 186 1267 1763, dushd@pumch.cn
Shunda Du, Doctor
- Not yet recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Jianqiang Cai, Doctor, +86 137 0113 5094, caijianqiang188@sina.com
Jianqiang Cai, Doctor
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Jia Luo, Doctor, +86 138 7499 4359, luojia@hnca.org.cn
Jia Luo, Doctor
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Shanzhi Gu, Doctor, +86 135 7486 5998, 105575191@qq.com
Shanzhi Gu, Doctor
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Tongsen Zheng, Doctor, +86 151 3456 9619, zhengtongsen@126.com
Tongsen Zheng, Doctor
- Recruiting
The First Affiliated Hospital of USTC
Hefei, Anhui, 230022
Yongsheng Ge, Doctor, +86 139 5600 2010, sygys@139.com
Yongsheng Ge, Doctor
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Yong Li, Doctor, +86 158 7915 5066, liyongcsco@qq.com
Yong Li, Doctor
- Recruiting
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 130061
Jia Fan, Doctor, +86 021-64041990, fan.jia@zs-hospital.sh.cn
Jian Zhou, Doctor, +86 021-64041990, zhou.jian@zs-hospital.sh.cn
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine City:Shanghai
Shanghai, Shanghai Municipality, 200025
Jun Zhang, Doctor, +86 138 1833 2497, junzhang@188.com
Jun Zhang, Doctor
- Not yet recruiting
Shanghai East Hospital,School of Medicine, Tongji University
Shanghai, Shanghai Municipality, 200120
Yong Gao, Doctor, +86 133 1016 7477
Yong Gao, Doctor
- Not yet recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110801
Xiujuan Qu, Doctor, +86 136 0403 1355, cmu1h_zlnk_trial@163.com
Xiujuan Qu, Doctor
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 451191
Shuijun Zhang, Doctor, +86 137 0395 1226, zhangshuijun@zzu.edu.cn
Shuijun Zhang, Doctor
About this study
Official title: A Phase II, Open-label, Multi-center Study to Evaluate the Safety and Efficacy of JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma（HCC）
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.
Read the detailed description
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, namely dose exploration stage (3-12 cases) and random expansion stage (40-60 cases).Dose-finding phase: This phase was designed to initially evaluate the tolerability and safety of JS207 combined with JS007 in patients with advanced HCC, and to determine the expansion dose. JS207 was administered at a fixed dose of 10 mg/kg every 3 weeks (Q3W). A Bayesian optimal interval (BOIN) design was used to explore the dose and frequency of JS007 administration (every 3-week treatment cycle, with a DLT observation period of 21±3 days after the first dose). For subjects who received the initial dose of dose 1 (a single dose of 3 mg/kg, 1 mg/kg every 6 weeks starting cycle 5 [Q6W]), the results were according to the BOIN design: if the dose was judged to be increased, dose 2 (3 mg/kg Q6W, 1 mg/kg Q6W starting cycle 5) was used for subsequent subjects. Dose 3 (1 mg/kg Q3W, followed by 1 mg/kg Q6W from cycle 5) was used for subsequent subjects if dose reduction or maintenance was judged. Dose 2 or dose 3 was similarly explored using the BOIN design.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.
Randomized expansion phase: This phase was designed to initially evaluate the efficacy of JS207 alone or in combination with JS007 in the first-line treatment of subjects with advanced HCC, as well as to further evaluate their safety. The randomized expansion phase planned to enroll approximately 40 to 60 subjects who would be randomly assigned in A 1:1 ratio to receive JS207 plus JS007 (cohort A) or JS207 alone (cohort B). Randomization stratification factor: baseline AFP level (<400ng/mL vs. ≥400ng/mL).Dose reductions or increases in JS207 and JS007 were not allowed during the study period, and drug interruptions or discontinuation were allowed. Neither JS207 nor JS007 was given for a maximum of 2 years. When a study drug was discontinued for any reason, the other study drugs could be continued.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- JS207, JS007
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS207Drug
10 mg/kg q3W or adjust the dose (e.g. 15 mg/kg) based on accumulated data on the safety and efficacy of JS207 from clinical studies.
JS007Drug
Dose exploration stage: C1-C4, group 1:3 mg/kg, C1D1 once (single dose); Group 2:3 mg/kg, D1, Q6W; Group 3:1 mg/kg,D1, Q3W; ≥C5, 1 mg/kg, Q6W; Dose expansion stage: according to the group medication confirmed in the dose exploration stage.
| Study group | Role | What they receive |
|---|---|---|
| JS207 Combined with JS007-ArmA | Experimental | Not described Receives: Drug: JS207; Drug: JS007 |
| JS207 monotherapy-ArmB | Experimental | Not described Receives: Drug: JS207 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
All adverse events, regardless of relationship to the study drug, were reported from the time the study drug was started until 90 days after the last dose or the subject started a new antineoplastic therapy, whichever occurred first.
Measured: up to 27 mouths
SAE
Only those resulting from interventions required by the protocol were reported from the time of ICF signing until the first dose. All were reported from the time of the first dose until 90 days after the last dose or initiation of a new antineoplastic therapy, after which, those considered to be related to previous study treatment were reported.
Measured: up to 27 mouths
DLT
Dose-limiting toxicity
Measured: up to 24 days after the first dose
ORR
Objective remission rate
Measured: up to 27 mouths
Secondary outcomes (7)
PFS
Progression free survival
Measured: up to 27 mouths
DCR
Disease control rate
Measured: up to 27 mouths
DOR
Duration of response
Measured: up to 27 mouths
OS
Overall survival
Measured: up to 27 mouths
The trough concentrations（PK）
To characterize the trough concentrations of JS207 and JS007
Measured: up to 27 mouths
Antidrug antibodies（ADA）
To characterize antidrug antibodies of JS207 and JS007
Measured: up to 27 mouths
Neutralizing antibody（Nab）
To characterize neutralizing antibody of JS207 and JS007
Measured: up to 27 mouths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start29 May 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954467
- Sponsor's protocol ID
- JS207-006-II-HCC
- Status last verified
- Jul 2025
- First submitted
- 18 Apr 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Multi-center Study to Evaluate the Safety and Efficacy of JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma（HCC）
- ClinicalTrials.gov ID
- NCT06954467
- Acronym / sponsor ID
- JS207-006-II-HCC
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 29 May 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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, namely dose exploration stage (3-12 cases) and random expansion stage (40-60 cases).Dose-finding phase: This phase was designed to initially evaluate the tolerability and safety of JS207 combined with JS007 in patients with advanced HCC, and to determine the expansion dose. JS207 was administered at a fixed dose of 10 mg/kg every 3 weeks (Q3W). A Bayesian optimal interval (BOIN) design was used to explore the dose and frequency of JS007 administration (every 3-week treatment cycle, with a DLT observation period of 21±3 days after the first dose). For subjects who received the initial dose of dose 1 (a single dose of 3 mg/kg, 1 mg/kg every 6 weeks starting cycle 5 [Q6W]), the results were according to the BOIN design: if the dose was judged to be increased, dose 2 (3 mg/kg Q6W, 1 mg/kg Q6W starting cycle 5) was used for subsequent subjects. Dose 3 (1 mg/kg Q3W, followed by 1 mg/kg Q6W from cycle 5) was used for subsequent subjects if dose reduction or maintenance was judged. Dose 2 or dose 3 was similarly explored using the BOIN design.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.
Randomized expansion phase: This phase was designed to initially evaluate the efficacy of JS207 alone or in combination with JS007 in the first-line treatment of subjects with advanced HCC, as well as to further evaluate their safety. The randomized expansion phase planned to enroll approximately 40 to 60 subjects who would be randomly assigned in A 1:1 ratio to receive JS207 plus JS007 (cohort A) or JS207 alone (cohort B). Randomization stratification factor: baseline AFP level (<400ng/mL vs. ≥400ng/mL).Dose reductions or increases in JS207 and JS007 were not allowed during the study period, and drug interruptions or discontinuation were allowed. Neither JS207 nor JS007 was given for a maximum of 2 years. When a study drug was discontinued for any reason, the other study drugs could be continued.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JS207 Combined with JS007-ArmA | Experimental | Drug: JS207, Drug: JS007 |
| JS207 monotherapy-ArmB | Experimental | Drug: JS207 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Willing to participate and sign a written informed consent form.
- Age ≥ 18 years, male or female.
- Patients with histologically/cytologically confirmed HCC or Hepatic cirrhosis meeting the criteria of the American Association for the Study of Liver Diseases (AASLD) can be enrolled.
- HCC classified as Barcelona Clinic Liver Cancer (BCLC) stage B (intermediate stage) or stage C (advanced stage), or stage IIa/IIb or IIIa/IIIb as defined by the Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition), prior to lymph node clearance, and deemed unsuitable for surgical and/or local treatment.
- No systemic therapy for HCC prior to study entry (mainly including systemic chemotherapy, targeted therapy, immunotherapy, etc.; adjuvant/neoadjuvant administration of small molecule anti-angiogenic drugs, such as lenvatinib, sorafenib, and donafenib, is allowed, but the last dose of these drugs must be administered ≥90 days prior to the first dose of the study drug).
Key exclusion criteria (23 listed)
- Received major surgery (requiring general anesthesia and >24 hours of hospitalization, excluding diagnostic biopsy), live vaccination, or investigational drug treatment within 4 weeks prior to the first dose, or received palliative radiotherapy for localized bone/brain lesions within 2 weeks prior to the first dose.
- Patients who are receiving chronic systemic corticosteroid therapy (daily dose >10 mg prednisone or other glucocorticoid with the same effect) or other immunosuppression therapy within 7 days prior to the first dose.
- Hepatic tumor burden > 50% of total hepatic volume at screening.
- Invasion of portal vein main trunk (Vp4) by cancer thrombus (more than 1/2 of lumen) as confirmed by CT/MRI examination.
- Presence of metastases to central nervous system of HCC; MRI scan of brain and/or spine is required to rule out the possibility when it is suspected.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JS20710 mg/kg q3W or adjust the dose (e.g. 15 mg/kg) based on accumulated data on the safety and efficacy of JS207 from clinical studies. | Drug | JS207 Combined with JS007-ArmA, JS207 monotherapy-ArmB |
| JS007Dose exploration stage: C1-C4, group 1:3 mg/kg, C1D1 once (single dose); Group 2:3 mg/kg, D1, Q6W; Group 3:1 mg/kg,D1, Q3W; ≥C5, 1 mg/kg, Q6W; Dose expansion stage: according to the group medication confirmed in the dose exploration stage. | Drug | JS207 Combined with JS007-ArmA |
Primary outcome
AE
Time frame: up to 27 mouths
All adverse events, regardless of relationship to the study drug, were reported from the time the study drug was started until 90 days after the last dose or the subject started a new antineoplastic therapy, whichever occurred first.
SAE
Time frame: up to 27 mouths
Only those resulting from interventions required by the protocol were reported from the time of ICF signing until the first dose. All were reported from the time of the first dose until 90 days after the last dose or initiation of a new antineoplastic therapy, after which, those considered to be related to previous study treatment were reported.
DLT
Time frame: up to 24 days after the first dose
Dose-limiting toxicity
ORR
Time frame: up to 27 mouths
Objective remission rate
7 secondary outcomes
PFS
Time frame: up to 27 mouths
DCR
Time frame: up to 27 mouths
DOR
Time frame: up to 27 mouths
OS
Time frame: up to 27 mouths
The trough concentrations（PK）
Time frame: up to 27 mouths
Antidrug antibodies（ADA）
Time frame: up to 27 mouths
Neutralizing antibody（Nab）
Time frame: up to 27 mouths
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JS207 and JS007 in people with Hepatocellular Carcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiazheng Yan, Master (+86 15822596147, jiazheng_yan@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (time frame: up to 27 mouths). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.