Neoplasms

All Conditions

Digestive System Diseases

Heart and Blood Diseases

Carcinoma

Carcinoma, Hepatocellular

Thrombosis

Venous Thrombosis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Embolism

Embolism and Thrombosis

Vascular Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Fluorouracil

Chlorotrianisene

Liver Extracts

Ethiodized Oil

neoadjuvant TACE-HAIC with surgery for HCC patients with PVTT

transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h+5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection

neo-TACE-HAIC+Surgery

hepatic resection remove the liver tumor and portal vein tumor thrombus

Surgery alone

Jiliang Qiu, MD.

Yunfei Yuan

Yunfei Yuan, MD.

Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. During the disease course, 20%-50% patients suffered portal vein tumor thrombus (PVTT), which is characterized with poor outcome and low response for treatments. Although BCLC (Barcelona clinical liver cancer) system recommend to palliative targeted treatment, the East Asian countries recommend to resection or transartery chemoembolization (TACE).

Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for advanced HCC.

Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate.

Whether TACE-HAIC would improve survival for patients with PVTT is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.

Neo-TACE-HAIC for PVTT-HCC

Neoadjuvant Transartery Chemoembolization Plus Artery Infusion Chemotherapy With Surgery Versus Surgery Alone for Hepatocellular Carcinoma Patients With Portal Vein Tumor Thrombus: a Randomized Clinical Trial

PFS was calculated from the date of starting treatment to the date of progression, of disease or death.

OS was calculated from the date of starting treatment to the date of death.

Sun Yat-sen University

Professor

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Tegafur

Antimetabolites

to receive oral uracil-tegafur 400 mg square meter for one year

UFT (uracil, tegafur)

Standardized mesorectal excision with selective lateral pelvic lymphadenectomy of stage III rectal cancer.

Shigeaki Yoshida, MD

This is a controlled study designed to compare relapse-free survival and overall survival in patients receiving UFT with those in patients receiving surgery alone. Patients will be randomly assigned to surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 12 months after the start of treatment.Evaluations will be separately done for colon cancer and rectal cancer.

A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)

A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone in Patients With Dukes C Colorectal Cancer (NSAS-CC)

Taiho Pharmaceutical Co., Ltd.

hepatic resection remove the liver tumors

transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h +5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection

Jiliang Qiu

Xuzhi Pan

Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. Although resection was recommend for early stage (BCLC A stage) patients according to the BCLC (Barcelona clinical liver cancer) system, increasing studies suggested that preoperative transarterial therapy may decrease the recurrence risk for those with high-risk factors. However, the clinical value is still undertermined. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC. Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC would improve survival for BCLC A stage patients with high-risk factors is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.

Neo-TACE-HAIC for High-risk BCLC A Stage HCC (NeoconceptA)

Neoadjuvant Transartery Chemoembolization Plus Artery Infusion Chemotherapy With Surgery Versus Surgery Alone for Hepatocellular Carcinoma Patients With High-risk Barcelona Clinic Liver Cancer (BCLC) A Stage: a Randomized Clinical Trial

PFS was calculated from the date of starting treatment to the date of progression, of disease or death

Rare Diseases

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

uracil-tegafur 360 mg per square meter per day orally 16 months

Gastrectomy of tumour node metastasis(TNM) stage T2N1-2 gastric cancer.

Toshifusa Nakajima, MD

This is a controlled study designed to evaluate the efficacy of UFT on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment response, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 16 months after the start of treatment.

A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-GC)

A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone for Serosa-negative Advanced Gastric Cancer (NSAS-GC)

Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. Although BCLC (Barcelona clinical liver cancer) system recommend to transarterial chemoembolization (TACE) for BCLC B stage patients, increasing studies suggested that hepatic resection provided survival benefit for those patients. However, a relative high recurrence risk leads surgeons to investigate the value of preoperative treatment.

Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC.

Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate.

Whether TACE-HAIC would improve survival for patients with BCLC B stage is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.

Neo-TACE-HAIC for BCLC B Stage HCC

Neoadjuvant Transartery Chemoembolization Plus Artery Infusion Chemotherapy With Surgery Versus Surgery Alone for Hepatocellular Carcinoma Patients With Barcelona Clinic Liver Cancer (BCLC) B Stage: a Randomized Clinical Trial

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Radical prostatectomy with lymph node dissection will be performed.

Darolutamide: 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg; for a total duration of 9 months. Darolutamide will start at day 1.

Surgery: radical prostatectomy with lymph node dissection will be performed after at least 3 months of darolutamide treatment.

Peri-operative darolutamide + surgery.

Guillaume PLOUSSARD

Loic MOUREY

Souhil LEBDAI

Franck BLADOU

Guilhem ROUBAUD

Alexandre DE LA TAILLE

Gaëlle FIARD

Jonathan OLIVIER

Jochen WALZ

Marc-Olivier TIMSIT

Morgan ROUPRÊT

Eric BARRET

Alain RUFFION

Romain MATHIEU

Yann NEUZILLET

Mathieu ROUMIGUIE

Franck BRUYERE

This is a phase II, multicenter, randomized open-label and comparative trial designed to study the effectiveness and the safety of androgen receptor antagonist (darolutamide) combined with surgery in patients with high-risk and/or locally advanced prostate cancer.

In this trial, patients will be assigned in one of the two following treatments arms:

* Arm A (control arm): Surgery alone (radical prostatectomy with lymph node dissection)
* Arm B (experimental arm): Peri-operative darolutamide + surgery (radical prostatectomy with lymph node dissection)

A total of 240 patients will have to be randomized with 120 patients in the control arm and 120 patients in the experimental arm.

SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer

Subscale Domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Prostate Cancer Subscale.

Responses to questions use a five-point Likert-type scale ranging from 0 ("not at all") to 4 ("very much so").

The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

The I-PSS is based on the answers to seven questions concerning urinary symptoms. Each question is assigned points from 0 (never) to 5 (almost always).

The IIEF is a 15-item questionnaire containing five domains including erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Each item is rated from 0 (or 1) (Severe ED/No sexual activity) to 5 (Mild/No ED).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neo-TACE-HAIC for PVTT-HCC	NCT04181931	Hepatocellular ... Portal Vein Thr...	neo-TACE-HAIC+S... Surgery alone	18 Years - 75 Years	Sun Yat-sen University
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)	NCT00152230	Colorectal Canc...	UFT (uracil, te... Surgery alone	20 Years - 75 Years	Taiho Pharmaceutical Co., Ltd.
Neo-TACE-HAIC for High-risk BCLC A Stage HCC (NeoconceptA)	NCT04777942	Hepatocellular ...	neo-TACE-HAIC+S... Surgery alone	18 Years - 75 Years	Sun Yat-sen University
Neo-TACE-HAIC for High-risk BCLC A Stage HCC (NeoconceptA)	NCT04777942	Hepatocellular ...	neo-TACE-HAIC+S... Surgery alone	18 Years - 75 Years	Sun Yat-sen University
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-GC)	NCT00152243	Gastric Cancer	UFT (uracil, te... Surgery alone	20 Years - 75 Years	Taiho Pharmaceutical Co., Ltd.
Neo-TACE-HAIC for BCLC B Stage HCC	NCT04424043	Hepatocellular ...	neo-TACE-HAIC+S... Surgery alone	18 Years - 75 Years	Sun Yat-sen University
SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer	NCT05826509	Prostate Cancer	Surgery alone Peri-operative ...	18 Years -	Institut Claudius Regaud
Neo-TACE-HAIC for BCLC B Stage HCC	NCT04424043	Hepatocellular ...	neo-TACE-HAIC+S... Surgery alone	18 Years - 75 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for surgery alone