Trial Outcomes & Findings for STOPPER CHINA:With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma (NCT NCT03113955)

Last Updated: 2021-12-01

Results Overview

The objective response rate measured by MRI used EASL (European Society for the Study of the Liver) and mRECIST (Improved criteria for evaluating the efficacy of solid tumors) , Overall Response (OR) = CR + PR. 1. Per Response Evaluation Criteria In Solid Tumors Criteria (mRECIST ) for target lesions : Complete Response (CR), Disappearance of any intratumoral arterial enhancement in all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions. 2. Per Response Evaluation Criteria In Solid Tumors Criteria (EASL) for target lesions: Complete Response (CR), Disappearance of all known disease and no new lesions determined by two observations not less than 4 weeks apart; Partial Response (PR), At least 50% reduction in total tumor load of all measurable lesions determined by two observations not less than 4 weeks apart.

Recruitment status

COMPLETED

Study phase

Target enrollment

109 participants

Primary outcome timeframe

At 6 months

Results posted on

2021-12-01

Participant Flow

Participant milestones

Participant milestones
Measure	Single -Arm A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma Tandem Microsphere loaded with Epirubicin: The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)
Overall Study STARTED	109
Overall Study COMPLETED	92
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single -Arm n=109 Participants A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma Tandem Microsphere loaded with Epirubicin: The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)
Age, Categorical <=18 years	0 Participants n=108 Participants • Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Age, Categorical Between 18 and 65 years	66 Participants n=108 Participants • Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Age, Categorical >=65 years	42 Participants n=108 Participants • Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Age, Continuous	60.22 years STANDARD_DEVIATION 8.67 • n=108 Participants • A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Sex: Female, Male Female	21 Participants n=108 Participants • A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Sex: Female, Male Male	87 Participants n=108 Participants • A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Race/Ethnicity, Customized Han of Chinese	108 Participants n=108 Participants • A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis
Region of Enrollment China	108 participants n=108 Participants • Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Child-Pugh Score Class A	97 Participants n=108 Participants • A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Child-Pugh Score Class B	11 Participants n=108 Participants • A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Disease History Diabetes	16 Participants n=108 Participants • Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Disease History Hypertension	25 Participants n=109 Participants • Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Disease History Cirrhosis	74 Participants n=109 Participants • Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Disease History Hepatitis B	90 Participants n=109 Participants • Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Disease History Hepatitis C	8 Participants n=109 Participants • Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
ECOG Performance Status 0 Score	97 Participants n=108 Participants • Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
ECOG Performance Status 1 Score	11 Participants n=109 Participants • Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.

PRIMARY outcome

Timeframe: At 6 months

Population: Total enrolled 109 subjects , 7 subjects were not completed 6 months primary endpoint follow up visit and were not included in the per protocol group for analysis. So overall Number of Participants Analyzed were 102.

Outcome measures

Outcome measures
Measure	Single -Arm n=102 Participants A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma Tandem Microsphere loaded with Epirubicin: The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)
Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging) 6-month ORR (EASL criteria)	75 participants
Number of Participants With Objective Tumor Response at 6 Months by MRI (Magnetic Resonance Imaging) 6-month ORR (mRECIST criteria)	73 participants

SECONDARY outcome

Timeframe: At 12 months

Population: Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.

Kaplan-Meier analyses the percent of participants for TTP which is defined as the length of time from the treatment initiation to either the date of the first disease progression occurred, as assessed by the investigators, or the date of the subject died due to any cause, whichever comes earlier. EASL and mRECIST response assessment of target lesion for HCC. TTP (also referred as "time to treatment failure") will be measured by a few data items list below: * The date of the disease progression in the Overall Response form * The date of lost-to-follow due to: * Adverse events * Progressive disease/insufficient therapeutic response * Death * Failure to return * Refusing treatment/being unwilling to cooperate/withdrawing consent * The very last date by scanning all available dates in the database * The desired cut-off days

Outcome measures

Outcome measures
Measure	Single -Arm n=108 Participants A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma Tandem Microsphere loaded with Epirubicin: The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)
Kaplan-Meier Analyses the Percent of Participants for Time to Progression (TTP) at 12 Months EASL	10 Percent of participants
Kaplan-Meier Analyses the Percent of Participants for Time to Progression (TTP) at 12 Months mRECIST	8 Percent of participants

SECONDARY outcome

Timeframe: At 1month

Outcome measures

Outcome measures
Measure	Single -Arm n=108 Participants A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma Tandem Microsphere loaded with Epirubicin: The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)
Number of Participants With Objective Tumor Response at 30-day EASL Response	86 Participants
Number of Participants With Objective Tumor Response at 30-day mRECIST Response	86 Participants

SECONDARY outcome

Timeframe: from first TACE to 12 months

Kaplan-Meier analyses the percent of participants for PPF which is defined as the length of time from the treatment initiation, that treated subjects are still progression-free. EASL and mRECIST response assessment of target lesion for HCC. The data items to be captured will include: * The date of the disease progression in the Overall Response form * The very last date by scanning all available dates in the database * The desired cut-off days The proportion of any time point will be determined by the Kaplan-Meier estimates.

Outcome measures

Outcome measures
Measure	Single -Arm n=108 Participants A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma Tandem Microsphere loaded with Epirubicin: The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)
Kaplan-Meier Analyses the Percent of Participants for PPF(Proportion Progression-Free) at 12 Months EASL	10 Percent of participants
Kaplan-Meier Analyses the Percent of Participants for PPF(Proportion Progression-Free) at 12 Months mRECIST	8 Percent of participants

SECONDARY outcome

Timeframe: from first TACE to 12 months

Population: Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment, 1 subject withdrew consent from study participation at 6 month, 1 subject withdrew consent from study participation at 12 month. All 3 subjects are not included in the group for overall survival analysis.

Kaplan-Meier analyses the percent of participants for Overall survival which is defined as the length of time from the treatment initiation, that treated subjects are still alive. The Kaplan-Meier analysis is aimed to capture the all-cause death for each subject. Subjects who are lost-to-follow will be considered being censored. There are three critical data items to be captured: * Death date * The very last date in the database (e.g. follow-up visit date and/or site reported AE date) * The desired cut-off days (e.g. 6-month OS at 182 days, 12-month OS at 365 days) In addition to the Kaplan-Meier survival curve, the median survival time (mOS) will also be used to represent the study cohort.

Outcome measures

Outcome measures
Measure	Single -Arm n=106 Participants A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma Tandem Microsphere loaded with Epirubicin: The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)
Kaplan-Meier Analyses the Percent of Participants for Overall Survival	100 Percent of participants

SECONDARY outcome

Timeframe: in 12 months

Number and documents of adverse events relate to study device in 12 months post procedure

Outcome measures

Outcome measures
Measure	Single -Arm n=108 Participants A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma Tandem Microsphere loaded with Epirubicin: The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)
Number of Adverse Events Relate to Study Device in 12 Months Post Procedure SAEs of related with TANDEM Microspheres	17 adverse events
Number of Adverse Events Relate to Study Device in 12 Months Post Procedure Non-serious AEs of related with TANDEM Microspheresrate	301 adverse events

SECONDARY outcome

Timeframe: At 3 months

Population: Total enrolled 109 subjects , 4 subjects were not completed 3 months primary endpoint follow up visit and were not included in the per protocol group for analysis. So overall Number of Participants Analyzed were 105.

Outcome measures

Outcome measures
Measure	Single -Arm n=105 Participants A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma Tandem Microsphere loaded with Epirubicin: The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)
Number of Participants With Objective Tumor Response at 3 Months EASL Response	84 Participants
Number of Participants With Objective Tumor Response at 3 Months mRECIST Response	85 Participants

SECONDARY outcome

Timeframe: At 12 month

Kaplan-Meier analyses the percent of participants for Time to Extrahepatic Spread which the length of time from the treatment initiation to the development of extrahepatic spread of the disease via imaging assessment. The data items to be considered will include: * The date of the extrahepatic spread in the Overall Response form * The very last date by scanning all available dates in the database * The desired cut-off days

Outcome measures

Outcome measures
Measure	Single -Arm n=108 Participants A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma Tandem Microsphere loaded with Epirubicin: The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)
Kaplan-Meier Analyses the Percent of Participants for Time to Extrahepatic Spread	20 Percent of participants

Adverse Events

Single -Arm

Serious events: 13 serious events

Other events: 75 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Single -Arm n=108 participants at risk A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma Tandem Microsphere loaded with Epirubicin: The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)
Hepatobiliary disorders Liver abscess	4.6% 5/108 • Number of events 6 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.93% 1/108 • Number of events 1 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer recurrent	0.93% 1/108 • Number of events 1 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.93% 1/108 • Number of events 1 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Gastrointestinal disorders Ascites	0.93% 1/108 • Number of events 1 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.93% 1/108 • Number of events 1 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Infections and infestations Sepsis	0.93% 1/108 • Number of events 1 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Hepatobiliary disorders Jaundice hepatocellular	0.93% 1/108 • Number of events 1 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Nervous system disorders Headache	0.93% 1/108 • Number of events 1 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
General disorders Pyrexia	0.93% 1/108 • Number of events 1 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Blood and lymphatic system disorders Anaemia	0.93% 1/108 • Number of events 1 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Injury, poisoning and procedural complications Post embolisation syndrome	0.93% 1/108 • Number of events 1 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.

Other adverse events

Other adverse events
Measure	Single -Arm n=108 participants at risk A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma Tandem Microsphere loaded with Epirubicin: The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)
Blood and lymphatic system disorders Investigations	21.3% 23/108 • Number of events 81 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Gastrointestinal disorders Gastrointestinal disorders	25.0% 27/108 • Number of events 48 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	55.6% 60/108 • Number of events 91 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
General disorders General disorders and administration site conditions	13.0% 14/108 • Number of events 18 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Hepatobiliary disorders Hepatobiliary disorders	13.0% 14/108 • Number of events 20 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Blood and lymphatic system disorders Blood and lymphatic system disorders	5.6% 6/108 • Number of events 6 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.
Metabolism and nutrition disorders Metabolism and nutrition disorders	6.5% 7/108 • Number of events 13 • 12 months Measure Analysis Population Description: Measure Analysis Population Description: A total of 109 subjects were enrolled, among them one subject coded as 3733S010 was confirmed as cholangiocarcinoma after being enrolled and receiving initial treatment. The subject continuously received follow-up but was not included in the per protocol group for analysis.

Additional Information

Dr. Gaojun Teng

Zhongda Hospital Southeast University

Phone: 13805171500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place