Hepatocellular Carcinoma Non-resectablePhase 2NCT06607107
mFOLFOX7 Plus Camrelizumab and Apatinib in BCLC Stage A/B Hepatocellular Carcinoma Patients Beyond Milan Criteria
A Phase 2 study testing mFOLFOX7 combined with Camrelizumab and apatinib in people with Hepatocellular Carcinoma Non-resectable, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This study was designed to evaluate the effectiveness and safety of mFOLFOX7（Oxaliplatin,Calcium Levofolinate,Fluorouracil） combined with Apatinib and Camrelizumab for Hepatocellular Carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable
- What is being tested?
- mFOLFOX7 combined with Camrelizumab and apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2024to 11 Jan 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Before treatment, histologically or cytologically or clinically diagnosed as hepatocellular carcinoma (HCC) and the clinical stage belongs to BCLC stage A/B HCC that exceeds the Milan criteria.
- Child-pugh liver function grading: Grade A or B
- Did not received any type of other first-line drugs such as Sorafenib or Lenvatinib.
- According to RECIST 1.1 standard and mRECIST standard, patients have at least one measurable lesion (CT scan long diameter ≥10mm and the lesion has not received radiotherapy, freezing or other local treatments)；
- ECOG PS score 0-2;
- Expected survival ≥ 12 weeks;
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- Blood routine:White blood cells count ≥3.0×10^9/L Platelet count ≥70×10^9/L Hemoglobin ≥80g/L(without blood transfusion within 14 days); kidney function: Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value (ULN); Liver function:Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); AST or ALT levels ≤ 3 times the upper limit of normal value (ULN)
- Patients with hepatitis B or C coinfection need to use antiviral drugs and have not used interferon.
- Women of childbearing age should have a negative serum or urine pregnancy test within 7 days before enrollment and they must be non-lactating patients and agree to use contraceptive measures during the study period and within 6 months after the end of the study. Men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period.
- Patients volunteered to participate in this study and signed informed consent;
Who cannot join
- Have received immunotherapeutic drugs or interferon in the past.
- Allergic to the drugs in the treatment ;
- Female subjects with pregnancy or on feeding.
- Have received other immunotherapy drugs (targeting PD1/PDL1).
- Patients with combined uncontrolled cardiac clinical symptoms or diseases, such as: (1) heart failure above NYHA class II; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; (5) those with poorly controlled hypertension by drugs and assessed by doctors as having a high risk of using apatinib.
- Past medical history includes other tumors or a second tumor, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ and papillary thyroid cancer.
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- Combined with severe infection (CTCAE greater than grade 2) before the start of treatment, such as severe pneumonia requiring hospitalization, active tuberculosis, bacteremia, infectious complications, etc.; baseline chest imaging examination indicates active pulmonary inflammation. There are symptoms and signs of infection within 2 weeks before the first use of the study drug or oral or intravenous antibiotic treatment is required (excluding prophylactic use of antibiotics).
- Have a history of immunodeficiency, such as positive HIV monitoring, have other acquired or congenital immunodeficiency diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes), or have a history of organ transplantation or bone marrow transplantation; or are taking hormones or other immunosuppressive drugs orally or intravenously; but excluding vitiligo or cured childhood asthma/allergies, and patients who do not require any intervention as adults.
- Severe coagulation disorders (INR>2.0, PT>16s), those with obvious bleeding tendencies (including but not limited to vomiting blood and having bloody stools every day in the past 3 months).
- Have the history of abusing psychotropic drugs and unable to quit ,or with mental disorders; with brain metastases or hepatic encephalopathy.
- As judged by the investigator, the patient may have other factors that may cause the study to be terminated prematurely, such as other serious diseases or serious abnormal laboratory tests or accompanied by other family or social factors that will affect the safety of the subject or the collection of trial data and samples.
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, Prof, 13710591214, 515332927@qq.com
About this study
Official title: A Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Systemic Chemotherapy(mFOLFOX7) Combined With Camrelizumab and Apatinib in BCLC Stage A/B Hepatocellular Carcinoma Patients Beyond Milan Criteria
This study was designed to evaluate the effectiveness and safety of mFOLFOX7（Oxaliplatin,Calcium Levofolinate,Fluorouracil） combined with Apatinib and Camrelizumab for Hepatocellular Carcinoma.
The primary outcome measure is to evaluate the primary pathological response (MPR) rate of the therapy for Hepatocellular Carcinoma.
Read more
The secondary Outcome measures include the objective response rate (ORR), the duration of response (DOR), disease control rate (DCR), progression-free survival rate (PFSR) [ Time Frame: 6- and 12-month], overall survival rate (OSR) [ Time Frame: 6- and 12-month], the median progression-free survival time (mPFS) and median overall survival time (mOS) of the therapy for Hepatocellular Carcinoma.
Moreover, this study aims to assess the safety and tolerability of the Therapy for Hepatocellular Carcinoma.
Read the detailed description
Hepatocellular carcinoma(HCC) is a common high-grade malignant tumor in my country, with limited treatment options and poor prognosis.
Early and middle stage (BCLC A or B) surgical resection is the main curative method for liver cancer, except for a few very early stages. Small liver cancer has a high short-term recurrence rate after surgery, with a median survival time of about 2 years and a 5-year survival rate of<20%. Treatment objectives for advanced liver cancer.
Previously, systemic therapy and transcatheter arterial chemoembolization(TACE) were mainly used for treatment, while targeted therapy and immunotherapy in systemic therapy have made rapid progress in recent years.
Trastuzumab and chemotherapy can increase the ORR of human epidermal growth factor receptor 2(HER2) positive advanced gastric cancer from 51.9% to 74.4%.
Preliminary small sample studies have shown that veins the combination of mFOLFOX7 regimen with Carolizumab and Apatinib may be a potential treatment for CNLC stage III hepatocellular carcinoma.A strategy that is effective, safe, and easy to implement, with preliminary research results similar to FOLFOX-HAIC combined with targeted immunotherapy. Especially for patients with concomitant main portal vein tumor thrombus showed very good results, and the extremely low microvascular invasion(MVI) in postoperative pathology also suggests the possibility of good therapeutic value for microvascular metastasis of liver cancer.
The Milan standard is an international standard used in liver transplantation, and patients who meet the standard have a lower recurrence rate and a longer lifespan.Survival period, specifically as follows: (1) The diameter of a single tumor does not exceed 5 cm; (2) The number of multiple tumors should not exceed 3 and the most Large diameter not exceeding 3cm; (3) The tumor has no invasion of large hepatic vessels or distant metastasis. We can also find that the Milan standard can significantly distinguish the treatment effect of liver cancer, and surpassing Milan's standard liver cancer has a significantly higher early recovery rate. There are also studies showing that liver cancer patients who exceed Milan's standards are receiving downgraded treatment of the overall survival rate and disease progression free survival rate after liver transplantation in patients who meet Milan's criteria are correlated with the overall survival rate after liver transplantation nearly. Therefore, in our study, neoadjuvant therapy targeting liver cancer with a high risk of recurrence has a high clinical value. The significance and expectation of camrelizumab and apatinib combined with intravenous mFOLFOX7 chemotherapy regimen are to improve the MPR rate of liver cancer treatment and reduce patient risk.
The MVI rate is increased to achieve a phase reduction effect and prolong the patient's life
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Being tested
- mFOLFOX7 combined with Camrelizumab and apatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFOX7 combined with Camrelizumab and apatinibDrug
Also called mFOLFOX7 plus Camrelizumab and apatinib
mFOLFOX7(Oxaliplatin 85mg/m2, Calcium Levofolinate 200mg/m2, Fluorouracil 400 mg/m2 D1，2400mg/m2 maintain 46 hours，) combined with Apatinib and Camrelizumab 200mg every 3 weeks. Taking Apatinib-Mesylate Tablets (250 mg/tablet) orally after meals, once a day, for continuous medication.
| Study group | Role | What they receive |
|---|---|---|
| mFOLFOX7 combined with Apatinib and Camrelizumab | Experimental | mFOLFOX7(Oxaliplatin, Calcium Levofolinate, Fluorouracil) combined with Apatinib and Camrelizumab Receives: Drug: mFOLFOX7 combined with Camrelizumab and apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response (MPR) rate
MPR rate is defined as the proportion of participants with =<10% residual viable tumor in the tumor bed at the time of surgery, as assessed by central pathological review.
Measured: 6 months
Secondary outcomes (9)
Objective Response Rate(ORR) by RECIST 1.1
ORR is the proportion of patients who achieved a complete or partial response during or after treatment
Measured: 6 months
pathologic complete response (pCR) rate
pCR is the proportion of surgical specimens with no tumor lesion or only carcinoma in situ.
Measured: 6 months
Duration of remission(DOR) by mRECIST
DOR is the time between the first assessment of the tumor as a complete or partial response and the first assessment as tumor progression or death.
Measured: 12 months
Disease Control Rate(DCR) by mRECIST
DCR is the proportion of all patients who have tumors that shrink or remain stable and stay that way for a certain period of time.
Measured: 6 months
Disease-free-survival(DFS) by RECIST 1.1
DFS is the time from the beginning of radical surgery to the first recurrence of the tumor and metastasis or death of patient for any reason.
Measured: 12 months
Progression-Free Survival (PFS) by RECIST 1.1
PFS is intended to be the time during or after treatment when there is no disease progression.
Measured: 12 months
Overall Survival (OS) by RECIST 1.1
OS is from the point at which treatment begins or the disease is diagnosed to the time at which the patient dies.
Measured: 24 months
Progression-Free Survival rate (PFSR) by RECIST 1.1
PFSR is the proportion of progression-free survival patients.
Measured: 12 months
Overall Survival Rate (OSR) by RECIST 1.1
OSR is the proportion of all surviving patients.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start17 Feb 2024
- Primary completion11 Jan 2026 (estimated)
- Study completion11 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- linhui Peng, Prof, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607107
- Sponsor's protocol ID
- SYSKY-2024-107-01
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- 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 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Systemic Chemotherapy(mFOLFOX7) Combined With Camrelizumab and Apatinib in BCLC Stage A/B Hepatocellular Carcinoma Patients Beyond Milan Criteria
- ClinicalTrials.gov ID
- NCT06607107
- Acronym / sponsor ID
- SYSKY-2024-107-01
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 17 Feb 2024 (actual)
- Primary completion
- 11 Jan 2026 (estimated)
- Study completion
- 11 Jan 2028 (estimated)
- First posted
- 23 Sep 2024 (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 study was designed to evaluate the effectiveness and safety of mFOLFOX7（Oxaliplatin,Calcium Levofolinate,Fluorouracil） combined with Apatinib and Camrelizumab for Hepatocellular Carcinoma.
The primary outcome measure is to evaluate the primary pathological response (MPR) rate of the therapy for Hepatocellular Carcinoma.
The secondary Outcome measures include the objective response rate (ORR), the duration of response (DOR), disease control rate (DCR), progression-free survival rate (PFSR) [ Time Frame: 6- and 12-month], overall survival rate (OSR) [ Time Frame: 6- and 12-month], the median progression-free survival time (mPFS) and median overall survival time (mOS) of the therapy for Hepatocellular Carcinoma.
Moreover, this study aims to assess the safety and tolerability of the Therapy for Hepatocellular Carcinoma.
Detailed description
Hepatocellular carcinoma(HCC) is a common high-grade malignant tumor in my country, with limited treatment options and poor prognosis.
Early and middle stage (BCLC A or B) surgical resection is the main curative method for liver cancer, except for a few very early stages. Small liver cancer has a high short-term recurrence rate after surgery, with a median survival time of about 2 years and a 5-year survival rate of<20%. Treatment objectives for advanced liver cancer.
Previously, systemic therapy and transcatheter arterial chemoembolization(TACE) were mainly used for treatment, while targeted therapy and immunotherapy in systemic therapy have made rapid progress in recent years.
Trastuzumab and chemotherapy can increase the ORR of human epidermal growth factor receptor 2(HER2) positive advanced gastric cancer from 51.9% to 74.4%.
Preliminary small sample studies have shown that veins the combination of mFOLFOX7 regimen with Carolizumab and Apatinib may be a potential treatment for CNLC stage III hepatocellular carcinoma.A strategy that is effective, safe, and easy to implement, with preliminary research results similar to FOLFOX-HAIC combined with targeted immunotherapy. Especially for patients with concomitant main portal vein tumor thrombus showed very good results, and the extremely low microvascular invasion(MVI) in postoperative pathology also suggests the possibility of good therapeutic value for microvascular metastasis of liver cancer.
The Milan standard is an international standard used in liver transplantation, and patients who meet the standard have a lower recurrence rate and a longer lifespan.Survival period, specifically as follows: (1) The diameter of a single tumor does not exceed 5 cm; (2) The number of multiple tumors should not exceed 3 and the most Large diameter not exceeding 3cm; (3) The tumor has no invasion of large hepatic vessels or distant metastasis. We can also find that the Milan standard can significantly distinguish the treatment effect of liver cancer, and surpassing Milan's standard liver cancer has a significantly higher early recovery rate. There are also studies showing that liver cancer patients who exceed Milan's standards are receiving downgraded treatment of the overall survival rate and disease progression free survival rate after liver transplantation in patients who meet Milan's criteria are correlated with the overall survival rate after liver transplantation nearly. Therefore, in our study, neoadjuvant therapy targeting liver cancer with a high risk of recurrence has a high clinical value. The significance and expectation of camrelizumab and apatinib combined with intravenous mFOLFOX7 chemotherapy regimen are to improve the MPR rate of liver cancer treatment and reduce patient risk.
The MVI rate is increased to achieve a phase reduction effect and prolong the patient's life
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mFOLFOX7 combined with Apatinib and Camrelizumab | Experimental | Drug: mFOLFOX7 combined with Camrelizumab and apatinibmFOLFOX7(Oxaliplatin, Calcium Levofolinate, Fluorouracil) combined with Apatinib and Camrelizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Before treatment, histologically or cytologically or clinically diagnosed as hepatocellular carcinoma (HCC) and the clinical stage belongs to BCLC stage A/B HCC that exceeds the Milan criteria.
- Child-pugh liver function grading: Grade A or B
- Did not received any type of other first-line drugs such as Sorafenib or Lenvatinib.
- According to RECIST 1.1 standard and mRECIST standard, patients have at least one measurable lesion (CT scan long diameter ≥10mm and the lesion has not received radiotherapy, freezing or other local treatments)；
- ECOG PS score 0-2;
Key exclusion criteria (11 listed)
- Have received immunotherapeutic drugs or interferon in the past.
- Allergic to the drugs in the treatment ;
- Female subjects with pregnancy or on feeding.
- Have received other immunotherapy drugs (targeting PD1/PDL1).
- Patients with combined uncontrolled cardiac clinical symptoms or diseases, such as: (1) heart failure above NYHA class II; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; (5) those with poorly controlled hypertension by drugs and assessed by doctors as having a high risk of using apatinib.
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 |
|---|---|---|
| mFOLFOX7 combined with Camrelizumab and apatinibAlso: mFOLFOX7 plus Camrelizumab and apatinibmFOLFOX7(Oxaliplatin 85mg/m2, Calcium Levofolinate 200mg/m2, Fluorouracil 400 mg/m2 D1，2400mg/m2 maintain 46 hours，) combined with Apatinib and Camrelizumab 200mg every 3 weeks. Taking Apatinib-Mesylate Tablets (250 mg/tablet) orally after meals, once a day, for continuous medication. | Drug | mFOLFOX7 combined with Apatinib and Camrelizumab |
Primary outcome
Major pathological response (MPR) rate
Time frame: 6 months
MPR rate is defined as the proportion of participants with =<10% residual viable tumor in the tumor bed at the time of surgery, as assessed by central pathological review.
9 secondary outcomes
Objective Response Rate(ORR) by RECIST 1.1
Time frame: 6 months
pathologic complete response (pCR) rate
Time frame: 6 months
Duration of remission(DOR) by mRECIST
Time frame: 12 months
Disease Control Rate(DCR) by mRECIST
Time frame: 6 months
Disease-free-survival(DFS) by RECIST 1.1
Time frame: 12 months
Progression-Free Survival (PFS) by RECIST 1.1
Time frame: 12 months
Overall Survival (OS) by RECIST 1.1
Time frame: 24 months
Progression-Free Survival rate (PFSR) by RECIST 1.1
Time frame: 12 months
Overall Survival Rate (OSR) by RECIST 1.1
Time frame: 24 months
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 23 Sep 2024.
- 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.
linhui Peng, Prof principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mFOLFOX7 combined with Camrelizumab and apatinib in people with Hepatocellular Carcinoma Non-resectable, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 10 inclusion and 11 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 23 Sep 2024. 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 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 linhui Peng, Prof (13710591214, 515332927@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response (MPR) rate (time frame: 6 months). 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 23 Sep 2024; AzTrials last refreshed its copy on 26 Oct 2026.