Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Carcinoma

Carcinoma, Hepatocellular

Recurrence

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Chlorotrianisene

Patients receive adjuvant Transcatheter Arterial Chemoembolization (TACE) following curative resection of HCC.

Patients do not receive TACE or any other adjuvant therapy following curative resection of HCC.

Participants enrolled in the adjuvant TACE group received one to two cycles of TACE with an interval of 4\~6 weeks, and the first TACE was given within 1 week after randomization.

Prophylactic Transcatheter Arterial Chemoembolization

Participants enrolled in the observation group were subjected to active surveillance without any adjuvant treatment.

Observation

Tingbo Liang, M.D Ph.D

1. Hepatocellular carcinoma (HCC) is the most common primary malignancy of liver, representing the third leading cause of cancer-related death worldwide.
2. Its overall dismal prognosis is a result of high incidence rates of metastasis and postoperative recurrence, in particular the intrahepatic recurrence.
3. TACE is the most widely used primary treatment for unresectable HCC. It was also used as the optional treatment for relapsed disease. However, the efficacy of TACE used as adjuvant therapy following hepatectomy remains controversial.

Eligible patients were between 18 and 75 years of age with histologically proven T1 or T2 HCC (according to the AJCC TNM Classification of HCC, 7th); an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Child-Pugh class A or B; no history of neoadjuvant therapy; no lymph node or distant metastasis; no intrahepatic or extrahepatic recurrence at radiological follow-up (4-6 weeks after surgery); adequate bone marrow, hepatic, and renal function according to laboratory test results. Patients were excluded if they had undergone margin-positive resections or resection of recurrence HCC; had lymph node or distal metastases; underwent concomitant ablation or radiation during surgery; were subjected to severe postoperative complications; had serious co-morbidities; had known allergy to iodine and drugs used in TACE; or if an investigator judged participation to be incompatible with the safety of the study. This clinical trial was done in accordance with the Declaration of Helsinki and local laws. All participants provided written informed consent. The study protocol was approved by the institutional Medical Ethics Review Committee.

Participants enrolled in the adjuvant TACE group received one to two cycles of TACE with an interval of 4\~6 weeks, and the first TACE was given within 1 week after randomization. Participants enrolled in the observation group were subjected to active surveillance without any adjuvant treatment. The TACE procedure was performed as follows. Briefly, a 4F or 5F catheter was introduced into the abdominal aorta through the superficial femoral artery according to the Seldinger technique. Angiography of the celiac and superior mesenteric arteries was performed to show the hepatic arterial supply. Then the left and right hepatic arteries were accessed by a microcatheter and intraarterial epirubicin (40 mg) and oxaliplatin (150 mg) in a mixture of lipiodol (3～5 mL) were injected. The follow-up interval was 3 months in the first two years postoperatively and 6 months thereafter. During each follow-up visit, blood tests including complete blood count, serum level of alpha-fetoprotein (AFP), and liver function tests were examined. During follow-up, contrast-enhanced abdominal CT or MRI scans were first performed at 3 months after operation and then every 6 months, with liver ultrasonography performed 3 months after every CT/MRI scan thereafter. Chest CT was performed at 1-year intervals. All participants with tumor recurrence were treated according to the decision made by a multidisciplinary board.

The primary endpoint was RFS, defined as the time from randomization to the first documented HCC recurrence by independent radiological assessment or death due to any cause, whichever occurred first. Secondary endpoints were OS (defined as the time from randomization to death due to any cause), RFS rate, and safety. Patients who were recurrence-free or alive at the point of final analysis were censored at the date of the last follow-up.

Intrahepatic recurrence was defined according to the non-invasive criteria of the European Association for the Study of the Liver (EASL) guideline. Newly-onset intrahepatic nodules with the longest diameter ≥ 1cm and a typical hallmark of HCC on contrast-enhanced CT/MRI imaging (hypervascular in the arterial phase with washout in the portal venous or delayed phase) were diagnosed as HCC recurrence. Lesions ≥ 1cm without a typical vascular pattern could also be diagnosed as HCC recurrence by evidence of a fast growth pattern as showed in subsequent scans and were independently reviewed by two radiologists. Extrahepatic recurrence was defined as per Response Evaluation Criteria in Solid Tumors. The safety of adjuvant TACE was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

After confirming eligibility by the investigators, patients without residual tumors on the CT/MRI were consented and randomly assigned in a 1:1 ratio into the adjuvant TACE group or the observation group. Allocation of treatment group was done with a computer-generated random number list.

Postoperative TACE(Transhepatic Arterial Chemotherapy And Embolization) for Patients With Hepatocellular Carcinoma

A Randomized, Open-label, Phase 3 Trial Evaluating Adjuvant Transarterial Chemoembolization for TNM Stage I and II Hepatocellular Carcinoma Recurrence After Curative Resection

defined as the time from randomization to the first documented HCC recurrence by independent radiological assessment or death due to any cause, whichever occurred first.

defined as the time from randomization to death due to any cause

Zhejiang University

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Topotecan

Cisplatin

Including criteria: cervical cancer patients after surgery with big tumor, deep invasion or tumor thrombi in the vascular system, but without lymph invasion, positive surgery margin or parametrium invasion. Patients in this group receive radiation therapy only. radiation therapy regimen: 3D-CRT pelvic radiation, 95%CTV DT 45Gy/25f. Radiation field include tumor bed and regional lymph nodes area. Upper border: branching of abdominal aorta. The radiation fields go down along the iliac vessels (including regions of 7mm out of the iliac vessels) and include the tumor bed region. Lower border: the inferior margin of obturator foramen.

Including criteria: cervical cancer patients after surgery with big tumor, deep invasion or tumor thrombi in the vascular system, but without lymph invasion, positive surgery margin or parametrium invasion. Patients in this group receive concurrent chemotherapy and radiation therapy. radiation therapy regimen is the same with radiation therapy only group. Chemotherapy regimen: Topotecan (1.5mg /m2 d1,2, 1mg d3) and Cisplatin (25mg /m2 d1-3). Chemotherapy will be carry out in the 2nd and 6th week of radiation therapy.

Including criteria: cervical cancer patients after surgery with big tumor, deep invasion or tumor thrombi in the vascular system, but without lymph invasion, positive surgery margin or parametrium invasion. Patients in this group receive concurrent chemotherapy and radiation therapy, and additional chemotherapy after concurrent treatment. radiation therapy regimen is the same with radiation therapy group. Chemotherapy regimen: Topotecan (1.5mg /m2 d1,2, 1mg d3) and Cisplatin (25mg /m2 d1-3). Chemotherapy will be carry out in the 2nd and 6th week of radiation therapy. Additional chemotherapy regimen is the same with concurrent chemotherapy, and will be carry out in the 4th and 8th week after radiation therapy.

Liu Zi, M.D

Wang Tao, M.D

Zi Liu, M.D

Tao Wang, M.D

Chen M W, M.D

The purpose of the research is to evaluate the effect of additional chemotherapy in postoperation therapy of cervical cancer patients with risk factors (big tumor, deep invasion or tumor thrombi in the vascular system).

Cervical cancer has a very high morbidity. Many patients need additional therapy after surgery in order to elevate the survival rate and life quality. In this research, we are going to give additional therapy to patients who have big tumor, deep invasion or tumor thrombi in the vascular system after surgery. randomized control method will be used in this research, in order to compare the survival rate and side effects between radiation therapy only, concurrent chemoradiotherapy, and concurrent chemoradiotherapy with additional chemotherapy. 3D-CRT and Topotecan will be used in this research.

Clinical Study in Post-operation Treatment of Cervical Cancer

Status and the Application of Topotecan at Post-operation Treatment of Cervical Cancer

Health Science Center of Xi'an Jiaotong University

Profesor

Antibodies

Immunoglobulins

Immunologic Factors

Treatment with Donafenib 100mg PO BID，and anti-PD-1 antibody 3mg/kg ivgtt Q2W. Treatment will last 6 months, unless the tumor recurrence.

Donafenib was taken orally twice daily, and anti-PD-1 antibody was applied biweekly.

Donafenib and anti-PD-1 antibody

Tingbo Liang, PhD

Yiwen Chen, MD

Hepatocellular carcinoma (HCC) is one of the most common malignant tumors, with more than 700,000 new cases in the world every year. China has the highest incidence and death rate of HCC in the world, accounting for 55% of the world's annual incidence and 45% of the world's annual deaths. At present, surgical resection is still one of the most effective treatments for HCC. However, the recurrence rate of tumor after hepatectomy is still very high, and the recurrence rate of 5 years is 60\~70%. Especially in patients with high-risk recurrence factors, without intervention, the cumulative recurrence rate in the first year was about 50%, about 60% in the second year, about 70% in the third year, and about 80% in the fifth year. Tumor recurrence is an important bottleneck that hinders the long-term survival of patients. Therefore, there is an urgent need for effective adjuvant therapy to reduce the postoperative recurrence rate of patients with HCC, especially high-risk patients. However, there is still a lack of standard protocols for postoperative adjuvant therapy for HCC. Here investigators intend to explore the safety and efficacy of Donafinib Combined With Anti-PD-1 Antibody as postoperative adjuvant therapy for HCC patients with high risks of recurrence.

This is a single center, open, single arm, and exploratory study. Thirty HCC patients with high risk recurrence factors after radical surgery will be enrolled. Adjuvant treatment of Donafenib combined with anti-PD-1 antibody will be given for 6 months. The primary endpoint is the cumulative percentage of patients without recurrence in the first year. The recurrence-free survival (RFS), overall survival (OS), tumor recurrence time (TTR), ECOG physical condition (ECOG PS) score, the changes of FACT-Hep based quality of life score, changes of AFP, and adverse events will be recorded and analyzed, to evaluated the efficacy and safety of this combination treatment.

Study on the Safety and Efficacy of Donafinib Combined With Anti-PD-1 Antibody as Adjuvant Therapy for HCC Patients

A Study on the Safety and Efficacy of Donafinib Combined With Anti-PD-1 Antibody as Adjuvant Therapy for HCC Patients With High Risks of Recurrence

The cumulative percentage of patients without recurrence in the first year after the primary surgery

The period from the first study treatment to disease recurrence

The period from the first study treatment to any cause of death

The changes of physical condition evaluated according to the criteria of Eastern Cooperative Oncology Group

Adverse events occurring through the study treatment, such as abnormalities or changes in laboratory examinations, physical examinations, vital signs, etc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Postoperative TACE(Transhepatic Arterial Chemotherapy And Embolization) for Patients With Hepatocellular Carcinoma	NCT02109146	Hepatocellular ... Transcatheter A...	Prophylactic Tr... Observation	18 Years - 80 Years	Zhejiang University
Clinical Study in Post-operation Treatment of Cervical Cancer	NCT01418859	Cervical Cancer		20 Years - 70 Years	Health Science Center of Xi'an Jiaotong University
Study on the Safety and Efficacy of Donafinib Combined With Anti-PD-1 Antibody as Adjuvant Therapy for HCC Patients	NCT04418401	Hepatocellular ...	Donafenib and a...	18 Years - 75 Years	Zhejiang University

Spots Global Cancer Trial Database for postoperation