Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Androgens

Hormones

Leuprolide

Goserelin

Prolactin Release-Inhibiting Factors

Triptorelin Pamoate

Bicalutamide

Androgen Antagonists

Flutamide

Buserelin

Antineoplastic Agents, Hormonal

Hormone Antagonists

Contraceptive Agents

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Patients will receive androgen-deprivation therapy comprising luteinizing-hormone releasing-hormone (LHRH) agonist (leuprolide acetate, goserelin acetate, buserelin, or triptorelin) subcutaneously or as an injection AND an oral antiandrogen therapy (flutamide 3 times daily or bicalutamide once daily).

Patients will receive androgen-deprivation therapy as in arm I in addition to definitive treatment including surgery to remove prostate or radiation therapy to the prostate.

goserelin acetate

flutamide

leuprolide acetate

triptorelin

surgery to remove prostate or radiation therapy to the prostate.

Definitive Treatment

Ye Dingwei, MD

The goal of this clinical research is to learn if treatment with androgen deprivation therapy in combination with surgery or radiation therapy can prolong the progression-free survival of oligometastatic prostate cancer than androgen deprivation therapy alone. The safety of this treatment combination will also be studied.

Today androgen deprivation therapy has been a standard treatment for metastatic prostate cancer, but as to the special type of prostate cancer-oligometastatic prostate cancer, except for androgen deprivation therapy, whether local treatment can be the part of treatment for it? The purpose of this study is to evaluate whether local treatment combined with androgen deprivation therapy can extend progression-free survival, as well as overall survival and life quality of patients of oligometastatic prostate cancer compared with androgen deprivation therapy alone.

Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery)

OMPCa-Shanghai: An Open-label, Randomized Prospective Phase II Trial of Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery) of the Primary Tumor in Oligometastatic Prostate Cancer

Quality of Life assessed by the EORTC QLQ-C30 questionnaire

Fudan University

Principal Investigator

Abiraterone Acetate

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

All recruited participants would receive long-term and unified systemic treatment. Systemic treatment is defined as chemical castration plus new-generation anti-androgen therapy.

For the primary lesion:

The preferred local treatment for primary lesion is radical prostatectomy. Patients who refuse surgery or whose tumors cannot be surgically resected after 3 months' systemic treatment could receive radical radiotherapy.

For the metastatic lesion:

Radiotherapy for metastatic lesions would be performed between 4 weeks and 24 weeks after the local treatment for primary lesion. Stereotactic body radiation therapy (SBRT) is preferred, which could treat all the detected lesions at once or in stages.

Leuprolide acetate

Goserelin acetate

Triptorelin acetate

Degarelix acetate

Abiraterone acetate

Apalutamide

Enzalutamide

Radical prostatectomy to remove prostate primary lesion

Local treatment for primary lesion

Radiotherapy for primary lesion

Stereotactic body radiation therapy or proton and heavy ion radiation therapy is preferred, which could treat all the lesions at once or treat different lesions in stages.

Radiotherapy for metastatic lesion

Bo Dai, Doctoral

Dai Bo, Doctor

Dingwei Ye, Doctoral

Oligo-metastatic prostate cancer (OMPCa) is considered as an intermediated state between localized and poly-metastatic disease. Various retrospective studies and prospective clinical trials are carrying out to validate whether patients with OMPCa could benefit from local treatment for both primary and metastatic lesions. The investigators here to conduct a unique clinical trial which OMPCa patients were confirmed by conventional imaging, and received a long-term enhanced systemic therapy accompanied by tumor-directed therapy.

Recent studies showed that metastatic lesion of prostate cancer may originate from both the primary and the existing metastatic lesion, thus, disease with limited number of metastatic lesions were considered as oligo-metastatic prostate cancer (OMPCa), an intermediated state between localized and poly-metastatic disease. For patients with newly diagnosed OMPCa, serval studies revealed that prostate radiation therapy could improve their clinical outcomes. For patients with oligo-recurrent prostate cancer, they could also be benefit from stereotactic ablative radiation therapy to the metastatic lesion. The investigators thus designed a distinct clinical trial including patients who were confirmed as oligo-metastatic disease by conventional imaging modality (CT, MRI and ECT) rather than PSMA PET-CT. This study also aimed to evaluate the therapeutic effects of tumor-directed treatment under the background of long-term enhanced systemic therapy, including abiraterone, enzalutamide or apalutamide. Here, the investigators proposed that, for patients with de novo oligo-metastatic prostate cancer, enhanced systemic treatment combined with radical treatment of primary lesion and radiotherapy of all accessible metastatic lesions may prolong their survival time without affecting their quality of life.

Enhanced Systemic Combined With Local Treatment for Primary and Metastatic Lesions in Oligo-metastatic Prostate Cancer

Long-term Effects of Enhanced Systemic Therapy and Tumor-directed Therapy for Newly Diagnosed Oligometastatic Prostate Cancer Confirmed by Conventional Imaging Modality: a Prospective, Single-arm Study.

Proportion of patients without radiographic progression after two years' treatment.

The soft-tissue lesion evaluation criterion was RECIST1.1, and the bone lesion evaluation criterion was PCWG3

Proportion of patients survived after two years' treatment.

Proportion of patients with no observed PSA progression after two years' treatment. PSA progression is defined as a confirmed increase in the PSA level from the nadir value by ≥25% and by ≥2 ng/ml.

Pathological response, defined as achieving either pCR or MRD at radical prostatectomy (RP). pCR is defined as the absence of morphologically identifiable carcinoma in the RP specimen. MRD will be defined as residual tumor in the RP specimen measuring ≤ 5 mm.

Professor

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Neoplasm Metastasis

Multiple Pulmonary Nodules

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Anti-Infective Agents

Central Nervous System Depressants

Ethanol

ctDNA is detected before curative treatment. Subjects with ctDNA positive before treatment will receive curative treatments for pulmonary nodules such as surgery, radio frequency ablation or stereotactic body radiotherapy. ctDNA will be detected after curative treatment and then every three months until progression or 2 years. At the same time, routine post treatment follow-up will be performed.

Subjects with ctDNA negative will undergo routine follow-up. ctDNA will be detected every three months until progression or 2 years.

ctDNA is detected before curative treatment. Subjects with ctDNA positive before treatment will receive curative treatments for pulmonary nodules such as surgery, radio frequency ablation or stereotactic body radiotherapy.

ctDNA is rechecked following treatment. Subjects with ctDNA positive after treatment will receive chemotherapy. Subjects with ctDNA negative after curative treatment will undergo routine follow-up.

After treatment, ctDNA will be detected every three months until progression or 2 years. At the same time, routine post treatment follow-up will be performed.

Radical surgical resection, local radiotherapy, radiofrequency ablation (RFA) or interventional therapy (absolute alcohol or cryotherapy).

The equipment used for RFA of lung lesions consisted of the radiofrequency generator (CelonLab POWER), cold circulation pump (Celon Aquaflow Ⅲ), radiofrequency needle electrode (Celon proSurge: T20, T30 and T40 is an electrode length of 20, 30 and 40 mm respectively, and maximum output power of 20, 30 and 40 W; Olympus Surgical Technologies Europe, Hamburg, Germany).

Local treatment

Junjie Peng, MD, PhD

Wenhua Li, MD, PhD

The clinical diagnosis and treatment of small pulmonary nodules (suspected to be lung metastases) in advanced colorectal cancer patients remain controversy. Previous studies have shown that tumor-informed circulating tumor DNA (ctDNA) blood testing can sensitively detect residual cancer. Postoperative ctDNA in colorectal cancer patients is a valuable biomarker to identify minimal residual disease (MRD) after radical resection, which is possibly useful in redefining the risk group of patients and guiding postoperative treatment. This study aimed to explore the clinical value of therapeutic strategies based on tumor-informed ctDNA test in advanved colorectal cancer patients with small pulmonary nodules.

Circulating Tumor DNA Guided Therapeutic Strategies for CRC Patients With Small Pulmonary Nodules

Circulating Tumor DNA Guided Therapeutic Strategies for Colorectal Cancer Patients With Small Pulmonary Nodules Suspected to be Metastases: an Open-Label, Prospective, Phase II Cohort Study

Shanghai OrigiMed Co., Ltd.

Junjie Peng

MD, PhD

Carcinoma

Carcinoma, Hepatocellular

Death

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Liver Diseases

Amino Acids

Lenvatinib

Immune Checkpoint Inhibitors

Chlorotrianisene

Tyrosine Kinase Inhibitors

Sorafenib

Protein Kinase Inhibitors

Antineoplastic Agents, Immunological

Tyrosine

ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib)

local treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc.

Systemic therapy plus Local treatment:

ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib) plus local treatment (TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc)

Lenvatinib Oral Product

Programmed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1

PD-1 inhibitor

Local treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc.

Changhai Li, Doctor

Xiaoping Chen

Xiaoping Chen, Doctor

China is a high-risk area of Hepatocellular Carcinoma (HCC). Although Chinese population accounts for 18.4% of the global population, the number of new HCC patients accounting for about half of the global, which seriously threatens the lives and health of the people. The investigators establish multi-center, retrospective research methods, collecting the data of HCC treatment with system treatment (ICIs and TKIs) plus or without local treatment in the last 3 years, comprehensive assessment of their efficacy and safety, explore whether the efficacy of system treatment combination local treatment showed better effect compared with system or local monotherapy. Our study will find a new way to improve the prognosis of HCC patients.

This was a multi-center, retrospective study involving 2000 patients with HCC receiving ICIs (Programmed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1)) and TKIs (Lenvatinib or Sorafenib), ICIs and TKIs plus local treatment (TAC, Hepatic artery infusion chemotherapy (HAIC), radiofrequency (RF) ablation, microwave ablation, radiotherapy, etc.), and local monotherapy between Jan, 2019 and Dec, 2021 in China. Efficacy was evaluated with objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to tumor progression (TTP), and 1year and 2 years overall survival (OS). Treatment-related adverse events (TRAEs) were recorded and graded. Efficacy and safety of three groups were compared. Stratified analysis was performed according to patients baseline characteristics and medication regimen for combination therapy.

Real-world Study of Efficacy and Safety of ICIs and TKIs Therapy for HCC

Efficacy and Safety of Immune Checkpoint Inhibitors (ICIs) and Tyrosine Kinase Inhibitors (TKIs) Therapy for Hepatocellular Carcinoma (HCC)：a Multicenter, Retrospective Study on the Real-world in China

We haven't decided whether it needs to cooperate with other PI.

Rate of participants with treatment-related adverse events as assessed by CTCAE v5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery)	NCT02742675	Prostate Cancer	Bicalutamide goserelin aceta... flutamide leuprolide acet... triptorelin Definitive Trea...	18 Years - 80 Years	Fudan University
Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery)	NCT02742675	Prostate Cancer	Bicalutamide goserelin aceta... flutamide leuprolide acet... triptorelin Definitive Trea...	18 Years - 80 Years	Fudan University
Enhanced Systemic Combined With Local Treatment for Primary and Metastatic Lesions in Oligo-metastatic Prostate Cancer	NCT05212857	Prostate Cancer	Leuprolide acet... Goserelin aceta... Triptorelin ace... Degarelix aceta... Abiraterone ace... Apalutamide Enzalutamide Local treatment... Radiotherapy fo... Radiotherapy fo...	18 Years - 80 Years	Fudan University
Circulating Tumor DNA Guided Therapeutic Strategies for CRC Patients With Small Pulmonary Nodules	NCT05495672	Advanced Colore... Circulating Tum...	Local treatment	18 Years - 80 Years	Fudan University
Real-world Study of Efficacy and Safety of ICIs and TKIs Therapy for HCC	NCT05420922	Hepatocellular ... Programmed Cell... Effects of Immu...	Lenvatinib Oral... PD-1 inhibitor Local treatment	18 Years -	Tongji Hospital
Real-world Study of Efficacy and Safety of ICIs and TKIs Therapy for HCC	NCT05420922	Hepatocellular ... Programmed Cell... Effects of Immu...	Lenvatinib Oral... PD-1 inhibitor Local treatment	18 Years -	Tongji Hospital
Circulating Tumor DNA Guided Therapeutic Strategies for CRC Patients With Small Pulmonary Nodules	NCT05495672	Advanced Colore... Circulating Tum...	Local treatment	18 Years - 80 Years	Fudan University
Enhanced Systemic Combined With Local Treatment for Primary and Metastatic Lesions in Oligo-metastatic Prostate Cancer	NCT05212857	Prostate Cancer	Leuprolide acet... Goserelin aceta... Triptorelin ace... Degarelix aceta... Abiraterone ace... Apalutamide Enzalutamide Local treatment... Radiotherapy fo... Radiotherapy fo...	18 Years - 80 Years	Fudan University
Real-world Study of Efficacy and Safety of ICIs and TKIs Therapy for HCC	NCT05420922	Hepatocellular ... Programmed Cell... Effects of Immu...	Lenvatinib Oral... PD-1 inhibitor Local treatment	18 Years -	Tongji Hospital

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