Hepatocellular CarcinomaPhase 2NCT03520257
The Study of Apatinib Plus Radiotherapy vs. Apatinib in the Treatment of Hepatocellular Carcinoma With BCLC-C Stage I and Stage II Portal Vein Tumor Thrombus
A Phase 2 study testing Apatinib and Radiotherapy in people with Hepatocellular Carcinoma, run by Guangxi Medical University.
Trial summary
This study uses to suppress the growth of tumors, extend the patient's survival time and improve the quality of life as much as possible. Through the treatment, the patient is given the chance to undergo surgical resection, thereby more effectively prolonging the OS. 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?
- Apatinib and Radiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 30 Jun 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age: ≥18 years old;
- An unresectable HCC patient who is in strict compliance with the criteria for diagnosis and treatment of primary liver cancer (2011 edition) or who has been diagnosed by pathological or cytological examination and has at least one measurable lesion;
- Child-Pugh Liver Function Rating: Grade A or better Grade B (≤ 7 points);
- Cheng's type I and type II (imaging evaluation of the tumor portal vein tumors did not reach the contralateral portal vein branch, and embolization does not exceed 50% of the portal vein diameter) PVTT BCLC-C patients;
- Clinical evaluation cannot tolerate radical surgical resection;
- The tumor is confined to the hepatic liver;
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- The first patient who had not received any anti-cancer comprehensive treatment before;
- ECOG PS score: 0-1 points;
- The expected survival period is ≥ 3 months;
- The normal function of the major organs is the following:
- Blood tests:
- HGB≥90 g/L;
- Neutrophil absolute count (ANC) ≥ 1.5 × 109/L;
- PLT≥60×109/L;
- Biochemical tests:
- ALB ≥ 29 g/L;
- ALT and AST <2.5ULN;
- TBIL ≤ 2ULN;
- Creatinine ≤1.5ULN; (Child-Pugh can only have 2 points for both albumin and bilirubin)
- Subjects voluntarily joined the study and signed informed consent. Good compliance and follow-up.
Who cannot join
- Pregnancy or breast-feeding women, or those who are unwilling or unable to take effective contraceptive measures if they have fertility, women who are of child-bearing age will have a pregnancy test (+) within 7 days before enrollment;
- Participated in other drug clinical trials within 8 weeks before the start of the study;
- History of other malignancies in the past 5 years;
- Ascites with clinical symptoms, which require therapeutic paracentesis or drainage;
- People with high blood pressure who are unable to fall within the normal range after treatment with antihypertensive drugs (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg);
- Arrhythmia with grade II or higher myocardial ischemia or myocardial infarction and poor control;
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- In accordance with NYHA criteria III-IV heart failure or cardiac ultrasound examination: LVEF (left ventricular ejection fraction) <50%;
- No other serious heart, lung, brain, kidney dysfunction;
- Has a variety of factors that affect oral medications (eg, inability to swallow, chronic diarrhea, and intestinal obstruction, which significantly affect drug use and absorption);
- In the past 6 months, there was a history of digestive tract bleeding or a clear tendency to gastrointestinal bleeding. For example, esophageal varices, local active ulcer lesions, fecal occult blood ≥ (++) with risk of bleeding may not be included in the group; If fecal occult blood (+) requires gastroscopy;
- Incidental arterial/venous thromboembolic events such as cerebrovascular accidents (including transient ischemic attacks), deep venous thrombosis, and pulmonary embolism within the first 6 months of study initiation;
- Coagulation abnormalities (INR> 1.5 or prothrombin time (PT)> ULN + 4 seconds) with bleeding tendency or receiving thrombolytic or anticoagulant therapy;
- Urinary cues suggest that urinary protein ≥ ++ and confirm 24-hour urinary protein quantification> 1.0 g;
- Those who have a history of abuse of psychotropic substances and are unable to get rid of or have a history of mental disorders;
- Existence of immune diseases or HIV infection;
- The investigator judges other situations that may affect the conduct of clinical studies and the findings of the study.
About this study
Official title: A Randomized Clinical Study of Apatinib Plus Radiotherapy vs. Apatinib in the Treatment of Hepatocellular Carcinoma With BCLC-C Stage I and Stage II Portal Vein Tumor Thrombus
This study uses to suppress the growth of tumors, extend the patient's survival time and improve the quality of life as much as possible. Through the treatment, the patient is given the chance to undergo surgical resection, thereby more effectively prolonging the OS. Apatinib is a small-molecule VEGFR tyrosine kinase inhibitor. It mainly treats malignant tumors by inhibiting VEGFR and exerting anti-angiogenic effects. Preclinical studies have shown that its anti-tumor effect is better than that of the similar drug PTK787. Phase II studies of hepatocellular carcinoma have initially demonstrated the effectiveness and safety of apatinib in the treatment of advanced HCC. Radiotherapy of tumors and portal vein tumor thrombi can promote further tumor shrinkage, and at the same time, the physiological basis for the recanalization of the original tumor thrombus itself will result in necrosis and fibrosis of the tumor thrombus, completely blocking the blood supply to the tumor portal vein. As a result, blood supply to the other side of the portal vein increases, and hepatocyte regeneration in a healthy liver is promoted, so that the patient can obtain surgical opportunities. Based on the therapeutic potential of apatinib and radiotherapy, we designed a prospective exploratory clinical study of this patient with advanced liver cancer.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Apatinib, Radiotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Apatinib, a small molecule anti-angiogenic targeted drug that has been demonstrated to be safe and effective after failure of standard chemotherapy for advanced gastric cancer, has been initially successful in phase II clinical trials for the treatment of unresectable advanced HCC patients. The efficacy of ralfiny in the treatment of Oriental population (ORIENTAL study) is better. The randomized, double-blind, multi-center phase III clinical study of apatinib second-line treatment of advanced hepatocellular carcinoma showed a good efficacy and safety. Currently, Phase III clinical studies of apatinib in HCC patients undergoing systemic chemotherapy or sorafenib treatment have progressed. Initial results also showed good efficacy and safety.
RadiotherapyDevice
Radiotherapy of tumors and portal vein tumor thrombi can promote further tumor shrinkage, and at the same time, the physiological basis for the recanalization of the original tumor thrombus itself will result in necrosis and fibrosis of the tumor thrombus, completely blocking the blood supply to the tumor portal vein. As a result, blood supply to the other side of the portal vein increases, and hepatocyte regeneration in a healthy liver is promoted, so that the patient can obtain surgical opportunities.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib Plus Radiotherapy | Experimental | Not described Receives: Drug: Apatinib; Device: Radiotherapy |
| Apatinib | Other | Not described Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start1 May 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion30 Jun 2019 (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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TaoBai, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520257
- Sponsor's protocol ID
- GuangxiMU-HCC
- Status last verified
- Apr 2018
- First submitted
- 17 Apr 2018
- Last updated
- 9 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Study of Apatinib Plus Radiotherapy vs. Apatinib in the Treatment of Hepatocellular Carcinoma With BCLC-C Stage I and Stage II Portal Vein Tumor Thrombus
- ClinicalTrials.gov ID
- NCT03520257
- Acronym / sponsor ID
- GuangxiMU-HCC
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 9 May 2018 (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 uses to suppress the growth of tumors, extend the patient's survival time and improve the quality of life as much as possible. Through the treatment, the patient is given the chance to undergo surgical resection, thereby more effectively prolonging the OS. Apatinib is a small-molecule VEGFR tyrosine kinase inhibitor. It mainly treats malignant tumors by inhibiting VEGFR and exerting anti-angiogenic effects. Preclinical studies have shown that its anti-tumor effect is better than that of the similar drug PTK787. Phase II studies of hepatocellular carcinoma have initially demonstrated the effectiveness and safety of apatinib in the treatment of advanced HCC. Radiotherapy of tumors and portal vein tumor thrombi can promote further tumor shrinkage, and at the same time, the physiological basis for the recanalization of the original tumor thrombus itself will result in necrosis and fibrosis of the tumor thrombus, completely blocking the blood supply to the tumor portal vein. As a result, blood supply to the other side of the portal vein increases, and hepatocyte regeneration in a healthy liver is promoted, so that the patient can obtain surgical opportunities. Based on the therapeutic potential of apatinib and radiotherapy, we designed a prospective exploratory clinical study of this patient with advanced liver cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib Plus Radiotherapy | Experimental | Drug: Apatinib, Device: Radiotherapy |
| Apatinib | Other | Drug: Apatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age: ≥18 years old;
- An unresectable HCC patient who is in strict compliance with the criteria for diagnosis and treatment of primary liver cancer (2011 edition) or who has been diagnosed by pathological or cytological examination and has at least one measurable lesion;
- Child-Pugh Liver Function Rating: Grade A or better Grade B (≤ 7 points);
- Cheng's type I and type II (imaging evaluation of the tumor portal vein tumors did not reach the contralateral portal vein branch, and embolization does not exceed 50% of the portal vein diameter) PVTT BCLC-C patients;
- Clinical evaluation cannot tolerate radical surgical resection;
Key exclusion criteria (16 listed)
- Pregnancy or breast-feeding women, or those who are unwilling or unable to take effective contraceptive measures if they have fertility, women who are of child-bearing age will have a pregnancy test (+) within 7 days before enrollment;
- Participated in other drug clinical trials within 8 weeks before the start of the study;
- History of other malignancies in the past 5 years;
- Ascites with clinical symptoms, which require therapeutic paracentesis or drainage;
- People with high blood pressure who are unable to fall within the normal range after treatment with antihypertensive drugs (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg);
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 |
|---|---|---|
| ApatinibApatinib, a small molecule anti-angiogenic targeted drug that has been demonstrated to be safe and effective after failure of standard chemotherapy for advanced gastric cancer, has been initially successful in phase II clinical trials for the treatment of unresectable advanced HCC patients. The efficacy of ralfiny in the treatment of Oriental population (ORIENTAL study) is better. The randomized, double-blind, multi-center phase III clinical study of apatinib second-line treatment of advanced hepatocellular carcinoma showed a good efficacy and safety. Currently, Phase III clinical studies of apatinib in HCC patients undergoing systemic chemotherapy or sorafenib treatment have progressed. Initial results also showed good efficacy and safety. | Drug | Apatinib, Apatinib Plus Radiotherapy |
| RadiotherapyRadiotherapy of tumors and portal vein tumor thrombi can promote further tumor shrinkage, and at the same time, the physiological basis for the recanalization of the original tumor thrombus itself will result in necrosis and fibrosis of the tumor thrombus, completely blocking the blood supply to the tumor portal vein. As a result, blood supply to the other side of the portal vein increases, and hepatocyte regeneration in a healthy liver is promoted, so that the patient can obtain surgical opportunities. | Device | Apatinib Plus Radiotherapy |
Primary outcome
overall survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib and Radiotherapy in people with Hepatocellular Carcinoma, run by Guangxi Medical University.
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 20 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 5 years). 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 9 May 2018.