Hepato Cellular Carcinoma (HCC)Phase 3NCT07267806
Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy for Advanced HCC
A Phase 3 study testing Infusional mFOLFOX7 plus Camrelizumab and apatinib and Camrelizumab and apatinib in people with Hepato Cellular Carcinoma (HCC) and Chemotherapy Effect, run by Linhui Peng at 1 site in China.
Trial summary
This is a multi-center randomized phase III clinical study of first-line Camrelizumab and Apatinib with or without intravenous FOLFOX Chemotherapy for Advanced Hepatocellular Carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepato Cellular Carcinoma (HCC), Chemotherapy Effect
- What is being tested?
- Infusional mFOLFOX7 plus Camrelizumab and apatinib and Camrelizumab and apatinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2025to Oct 2032
- Phase
- Phase 3
- 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
- Patients volunteered to participate in this study and signed informed consent;
- ≥18 years old, male and female;
- Before treatment, it was confirmed by histopathology or cytology, or clinically diagnosed as hepatomegaly.Patients with Hepatocellular Carcinoma, HCC);
- BCLC stage B or C hepatocellular carcinoma, which is not suitable for curative surgical or local therapies, or has progressed after such treatments.
- Local therapy (including but not limited to surgery, radiation therapy, transarterial chemoembolization [TACE], hepatic arterial infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) must have been completed at least 4 weeks prior to the baseline radiographic scan (with the exception of palliative radiotherapy, for which a 2-week interval is sufficient)."
- Has not received any systemic treatment for HCC.
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- According to RECIST 1.1 standard, patients have at least one measurable lesion (CT/MRI scan long diameter ≥10mm or CT/MRI scan short diameter ≥15mm for lymph node lesions, and the lesion has not received radiotherapy, freezing or other local treatments);
- Child-pugh liver function grading: Grade A or Grade Better B (≤7 points)
- ECOG PS score 0-2;
- Expected survival ≥ 12 weeks;
- Major organ functions are basically normal and meet the following requirements (within 7 days before starting the study treatment):
- Complete blood count: absolute neutrophil count ≥ 1.5*10^9/L, platelets (PLT) ≥ 75*10^9/L, hemoglobin ≥ 90 g/L;
- Blood biochemistry: albumin ≥ 25 g/L; total bilirubin ≤ 3.0 × upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 5 × ULN; creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CrCl) > 50 mL/min.
- International normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) no more than 6 seconds above the normal control range;
- Urine protein <2 (if urine protein ≥2, a 24-hour urine protein quantification can be performed; 24-hour urine protein <1.0 g is allowed for inclusion).
- Patients with active hepatitis B virus (HBV) infection must receive anti-HBV therapy prior to initiating study treatment and be willing to continue antiviral therapy throughout the study; hepatitis C virus (HCV) RNA-positive patients must receive antiviral therapy according to local standard treatment guidelines with liver function not exceeding CTCAE grade 1 elevation.
- Women of childbearing potential should have a negative serum or urine pregnancy test within 7 days prior to study enrollment, must not be breastfeeding, and must agree to use contraception during the study and for 6 months after the study; men must agree to use contraception during the study and for 6 months after the study.
- -
Who cannot join
- Known cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, and fibrolamellar carcinoma; having other active malignancies within the past 5 years or simultaneously, excluding HCC. Successfully treated localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., can be included.
- Patients who are preparing for or have previously undergone organ or allogeneic hematopoietic stem cell transplantation;
- Patients with clinical symptoms of moderate to severe ascites that require therapeutic puncture or drainage; uncontrolled pleural effusion or pericardial effusion of moderate amount or more;
- Patients with a history of gastrointestinal bleeding within 6 months before the start of the study treatment or a clear tendency for gastrointestinal bleeding, such as: high-risk or severe esophageal and gastric varices, localized active gastrointestinal ulcer lesions, or persistent positive fecal occult blood;
- Patients who have had abdominal fistulas, gastrointestinal perforation, or intra-abdominal abscesses within 6 months before the start of the study treatment;
- Patients with known hereditary or acquired bleeding disorders (such as coagulation dysfunction) or thrombophilia.
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- Currently using or having recently used (within 10 days before the start of the study treatment) aspirin [>325 mg/day (maximum antiplatelet dose)] or dipyridamole, ticlopidine, clopidogrel, and cilostazol;
- Occurrence of thrombotic or embolic events within 6 months before the start of the study treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction, pulmonary .embolism).
- Uncontrolled cardiac clinical symptoms or conditions, such as:
- Heart failure of NYHA class II or above;
- Unstable angina;
- Myocardial infarction occurring within the past year;
- Clinically significant supraventricular or ventricular arrhythmias requiring medical intervention;
- Patients with hypertension whose condition is poorly controlled by medication and who are assessed by a doctor to be at high risk when using apatinib;
- Suffering from hypertension that cannot be well controlled with antihypertensive medication (systolic ≥140 mmHg or diastolic ≥90 mmHg); history of hypertensive crises or hypertensive encephalopathy;
- Major vascular disease occurring within 6 months prior to the start of study treatment (e.g., an aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis);
- Severe, non-healing, or dehisced wounds, as well as active ulcers or untreated fractures;
- Undergoing major surgery (except for diagnosis) within 4 weeks before the start of study treatment or anticipated need for major surgery during the study period;
- Inability to swallow pills, malabsorption syndrome, or any condition affecting gastrointestinal absorption;
- History of intestinal obstruction and/or clinical signs or symptoms of gastrointestinal obstruction within 6 months before starting study treatment;
- Evidence of intra-abdominal gas that cannot be explained by puncture or recent surgery;
- Past or present central nervous system metastases; 18. History of hepatic encephalopathy.
- Currently accompanied by interstitial pneumonia or interstitial lung disease, or with a history of interstitial pneumonia or interstitial lung disease requiring steroid treatment, or other conditions that may interfere with the assessment and management of immune-related lung toxicity, such as pulmonary fibrosis, organizing pneumonia, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or severely impaired lung function; active tuberculosis;
- Currently accompanied by interstitial pneumonia or interstitial lung disease, or with a history of interstitial pneumonia or interstitial lung disease requiring steroid treatment, or other conditions that may interfere with the assessment and management of immune-related lung toxicity, such as pulmonary fibrosis, organizing pneumonia, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or severely impaired lung function; active tuberculosis;
- Subjects with active autoimmune diseases or a history of autoimmune diseases that may relapse (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects whose condition can be controlled solely with hormone replacement therapy may be included]); subjects with skin diseases that do not require systemic treatment such as vitiligo, psoriasis, or alopecia, subjects with type 1 diabetes controlled with insulin therapy, or subjects whose childhood asthma has fully resolved and require no intervention as adults may be included; subjects with asthma requiring medical intervention with bronchodilators cannot be included.
- Use of immunosuppressants or systemic steroid therapy within 14 days prior to the start of study treatment to achieve immunosuppression (dose >10 mg/day of prednisone or other equivalent steroids);
- Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications; oral or intravenous therapeutic antibiotics within 2 weeks prior to the start of study treatment (patients receiving prophylactic antibiotics are eligible for the study, such as for prevention of urinary tract infection or exacerbation of chronic obstructive pulmonary disease);
- Congenital or acquired immunodeficiency (e.g., HIV infection);
- Coinfection with hepatitis B and hepatitis C;
- Prior treatment with other anti-PD-1 antibodies or other PD-1/PD-L1 targeted immunotherapies, or prior treatment with apatinib;
- Vaccination with live attenuated vaccines within 28 days prior to the start of study treatment, or anticipated need for such vaccines during camrelizumab treatment or within 60 days after the last dose of camrelizumab;
- Treatment with other investigational drugs within 28 days prior to the start of study treatment.
- According to the researcher's judgment, the patient has other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other severe illnesses (including psychiatric disorders) requiring combined treatment, significant abnormalities in laboratory tests, or family or social factors that could affect the patient's safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Linhui Peng, 8613710591214, penglinhui2927@qq.com
About this study
Official title: Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy as First-Line Treatment for Advanced Hepatocellular Carcinoma (HCC): A Randomized, Controlled, Open-Label, Multicenter Phase III.
This is a multi-center randomized phase III clinical study of first-line Camrelizumab and Apatinib with or without intravenous FOLFOX Chemotherapy for Advanced Hepatocellular Carcinoma (HCC).
- Being tested
- Infusional mFOLFOX7 plus Camrelizumab and apatinib, Camrelizumab and apatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusional mFOLFOX7 plus Camrelizumab and apatinibDrug
Oxaliplatin 85mg/m2 IV on Days 1 of a 21 day cycle Fluorouracil 5-FU continuous infusion: 400mg/m2 on Dand then 2400mg/m2 for 46h of each 21 day cycle. this chemotherapy regimen should be administered for a maximum of 6 cycles. Camrelizumab 200mg infusion on D1 forevery 21 days Apatinib 250mg, po, qd for every 21 days.
Camrelizumab and apatinibDrug
Camrelizumab 200mg infusion on D1 forevery 21 days Apatinib 250mg, po, qd for every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Infusional FOLFOX | Experimental | Infusional mFOLFOX7 plus Camrelizumab and apatinib Receives: Drug: Infusional mFOLFOX7 plus Camrelizumab and apatinib |
| Excluding FOLFOX | Active comparator | Camrelizumab and Apatinib Receives: Drug: Camrelizumab and apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
The time from the start of treatment to the first progression of the patient's diseaseTime based on RECIST V1.1.
Measured: up to approximately 3 years
Overall Survival(OS)
The time between the start of treatment and the patient's deathTime.
Measured: up to approximately 5 years
Secondary outcomes (17)
Objective Response Rate(ORR)
ORR is defined as the proportion of patients who achieve a reduction in tumor size by a predefined amount within the shortest time frame based on REClSTv1.1. ORR is defined as the sum of partial response (PR) and complete response (CR), that is, the proportion of patients who achieve either PR or CR.
Measured: up to approximately 3 years
During of response(DOR)
how long a disease continues to respond to a treatment after the initial response is achieved, without the disease getting worse again based on RECIST v1.1.
Measured: up to approximately 3 years
Disease control rate(DCR)
The percentage of patients whose tumors shrink or stabilize for a certain period otime, including complete response (CR), partial response (PR), and stable (SD) cases. Patientswere evaluated once every 3 cycles during the 1st to 6th treatment cycle and once every 3months during the sequential treatment phase.
Measured: up to approximately 3 years
Time to progression(TTP)
It is defined as the time from the start of treatment (or randomisation) until the objective documentation of disease progression based on RECIST v1.1.
Measured: up to approximately 3 years.
Progression-Free Survival based on mRECIST(mPFS)
The time from the start of treatment to the first progression of the patient's diseaseTime based on mRECIST
Measured: up to approximately 3 years
Time to progression based on mRECIST(mTTP)
It is defined as the time from the start of treatment (or randomisation) until the objective documentation of disease progression based on mRECIST.
Measured: up to approximately 3 years.
Disease control rate based on mRECIST(mDCR)
The percentage of patients whose tumors shrink or stabilize for a certain period otime, including complete response (CR), partial response (PR), and stable (SD) cases based on mRECIST. Patientswere evaluated once every 3 cycles during the 1st to 6th treatment cycle and once every 3months during the sequential treatment phase.Time Frame: up to approximately 3 years
Measured: up to approximately 3 years
During of response based on mRECIST(mDOR)
how long a disease continues to respond to a treatment after the initial response is achieved, without the disease getting worse again based on mRECIST .
Measured: up to approximately 3 years
Objective Response Rate based on mREClST(mORR)
ORR is defined as the proportion of patients who achieve a reduction in tumor size by a predefined amount within the shortest time frame based on mREClST. ORR is defined as the sum of partial response (PR) and complete response (CR), that is, the proportion of patients who achieve either PR or CR.
Measured: up to approximately 3 years
6 months Progression-Free Survival Rate(6-mon-PFSR)
The incidence of disease progression within the first 6 months of the patient's treatment.
Measured: up to approximately 3 years
12 months Progression-Free Survival Rate(12-mon-PFSR)
The incidence of disease progression within the first 12 months of the patient's treatment.
Measured: up to approximately 3 years
18 months Progression-Free Survival Rate(18-mon-PFSR)
The incidence of disease progression within the first 18 months of the patient's treatment.
Measured: up to approximately 3 years.
12 months Overall Survival Rate(12-mon-OSR)
Proportion of patients surviving from the start of enrollment to the full 12 months of follow-up.
Measured: 2 years
24 months Overall Survival Rate(24-mon-OSR)
Proportion of patients surviving from the start of enrollment to the full 24 months of follow-up.
Measured: 2 years.
36 months Overall Survival Rate(36-mon-OSR)
Proportion of patients surviving from the start of enrollment to the full 36 months of follow-up.
Measured: 3 years.
Treatment-related Adverse Event(TRAE)
The classification of adverse events during treatment was based on NCI-CTCAE v5.0 criteria.
Measured: up to approximately 3 years.
Surgical Conversion Rate
Conversion of initially unresectable patients to resection.
Measured: up to approximately 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start31 Oct 2025
- Primary completionOct 2029 (estimated)
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepato Cellular Carcinoma (HCC)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm1: infusional FOLFOX plus Camrelizumab and Apatinib Arm2: Camrelizumab and Apatinib
- Masking
- None (open label)
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linhui Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Linhui Peng, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267806
- Sponsor's protocol ID
- SYSKY-2025-787-01
- Status last verified
- Oct 2025
- First submitted
- 25 Nov 2025
- Last updated
- 16 Dec 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy as First-Line Treatment for Advanced Hepatocellular Carcinoma (HCC): A Randomized, Controlled, Open-Label, Multicenter Phase III.
- ClinicalTrials.gov ID
- NCT07267806
- Acronym / sponsor ID
- SYSKY-2025-787-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Linhui PengUniversity, hospital or other
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 5 Dec 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 is a multi-center randomized phase III clinical study of first-line Camrelizumab and Apatinib with or without intravenous FOLFOX Chemotherapy for Advanced Hepatocellular Carcinoma (HCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm1: infusional FOLFOX plus Camrelizumab and Apatinib Arm2: Camrelizumab and Apatinib
| Arm | Type | Receives |
|---|---|---|
| Infusional FOLFOX | Experimental | Drug: Infusional mFOLFOX7 plus Camrelizumab and apatinibInfusional mFOLFOX7 plus Camrelizumab and apatinib |
| Excluding FOLFOX | Active comparator | Drug: Camrelizumab and apatinibCamrelizumab and Apatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients volunteered to participate in this study and signed informed consent;
- ≥18 years old, male and female;
- Before treatment, it was confirmed by histopathology or cytology, or clinically diagnosed as hepatomegaly.Patients with Hepatocellular Carcinoma, HCC);
- BCLC stage B or C hepatocellular carcinoma, which is not suitable for curative surgical or local therapies, or has progressed after such treatments.
- Local therapy (including but not limited to surgery, radiation therapy, transarterial chemoembolization [TACE], hepatic arterial infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) must have been completed at least 4 weeks prior to the baseline radiographic scan (with the exception of palliative radiotherapy, for which a 2-week interval is sufficient)."
Key exclusion criteria (33 listed)
- Known cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, and fibrolamellar carcinoma; having other active malignancies within the past 5 years or simultaneously, excluding HCC. Successfully treated localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., can be included.
- Patients who are preparing for or have previously undergone organ or allogeneic hematopoietic stem cell transplantation;
- Patients with clinical symptoms of moderate to severe ascites that require therapeutic puncture or drainage; uncontrolled pleural effusion or pericardial effusion of moderate amount or more;
- Patients with a history of gastrointestinal bleeding within 6 months before the start of the study treatment or a clear tendency for gastrointestinal bleeding, such as: high-risk or severe esophageal and gastric varices, localized active gastrointestinal ulcer lesions, or persistent positive fecal occult blood;
- Patients who have had abdominal fistulas, gastrointestinal perforation, or intra-abdominal abscesses within 6 months before the start of the study treatment;
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 |
|---|---|---|
| Infusional mFOLFOX7 plus Camrelizumab and apatinibOxaliplatin 85mg/m2 IV on Days 1 of a 21 day cycle Fluorouracil 5-FU continuous infusion: 400mg/m2 on Dand then 2400mg/m2 for 46h of each 21 day cycle. this chemotherapy regimen should be administered for a maximum of 6 cycles. Camrelizumab 200mg infusion on D1 forevery 21 days Apatinib 250mg, po, qd for every 21 days. | Drug | Infusional FOLFOX |
| Camrelizumab and apatinibCamrelizumab 200mg infusion on D1 forevery 21 days Apatinib 250mg, po, qd for every 21 days. | Drug | Excluding FOLFOX |
Primary outcome
Progression-Free Survival (PFS)
Time frame: up to approximately 3 years
The time from the start of treatment to the first progression of the patient's diseaseTime based on RECIST V1.1.
Overall Survival(OS)
Time frame: up to approximately 5 years
The time between the start of treatment and the patient's deathTime.
17 secondary outcomes
Objective Response Rate(ORR)
Time frame: up to approximately 3 years
During of response(DOR)
Time frame: up to approximately 3 years
Disease control rate(DCR)
Time frame: up to approximately 3 years
Time to progression(TTP)
Time frame: up to approximately 3 years.
Progression-Free Survival based on mRECIST(mPFS)
Time frame: up to approximately 3 years
Time to progression based on mRECIST(mTTP)
Time frame: up to approximately 3 years.
Disease control rate based on mRECIST(mDCR)
Time frame: up to approximately 3 years
During of response based on mRECIST(mDOR)
Time frame: up to approximately 3 years
Objective Response Rate based on mREClST(mORR)
Time frame: up to approximately 3 years
6 months Progression-Free Survival Rate(6-mon-PFSR)
Time frame: up to approximately 3 years
12 months Progression-Free Survival Rate(12-mon-PFSR)
Time frame: up to approximately 3 years
18 months Progression-Free Survival Rate(18-mon-PFSR)
Time frame: up to approximately 3 years.
12 months Overall Survival Rate(12-mon-OSR)
Time frame: 2 years
24 months Overall Survival Rate(24-mon-OSR)
Time frame: 2 years.
36 months Overall Survival Rate(36-mon-OSR)
Time frame: 3 years.
Treatment-related Adverse Event(TRAE)
Time frame: up to approximately 3 years.
Surgical Conversion Rate
Time frame: up to approximately 3 years.
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 16 Dec 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Infusional mFOLFOX7 plus Camrelizumab and apatinib and Camrelizumab and apatinib in people with Hepato Cellular Carcinoma (HCC) and Chemotherapy Effect, run by Linhui Peng at 1 site 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 18 inclusion and 33 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 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Linhui Peng (8613710591214, penglinhui2927@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: up to approximately 3 years). The study lists 2 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 16 Dec 2025.