Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Analgesics

Cytarabine

Venetoclax

Mitoxantrone

Azacitidine

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

2 cycles of VCA regimens followed by 2 cycles of D-MAG regimens, and then repeat the above four courses of treatment once

venetoclax combining chidamide and azacitidine (VCA) 28 days per cycle × 2 cycles； 1) chidamide 30mg biw × 2weeks；2) venetoclax 200mg/d × 2 weeks 3) azacitidine 100mg/d d1-7 dicitabine combined with liposome mitoxantrone, cytarabine, and G-CSF (D-MAG) regimen 28 days per cycle ×2 cycles；

1）dicitabine 25mg d1-3，2）liposome mitoxantrone 20mg d4，3）cytarabine 10mg/m2 Q12h d1-7 4）G-CSF 300ug d-1 until WBC \> 20×109/L

Venetoclax Combining Chidamide and Azacitidine (VCA) regimen followed by dicitabine combined with liposome mitoxantrone, cytarabine, and G-CSF (D-MAG) regimen

Bing Xu, M.D.

Zhifeng Li

Bing Xu

The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Elderly Patients with AML have inferior outcomes due to poor physical condition, and intolerant to conventional chemotherapy. The regimen of Venetoclax and Azacitidine has been widely used in these patients and has proved to achieve higher CR rate than low intensity therapy. However, the median duration of response (DOR) of this regimen is about one year. Chidamide is a histone deacetylase (HDAC) inhibitor and preclinical data showed adding low-dose Chidamide to venetoclax could significantly promoted apoptosis of leukemia cell lines. The Venetoclax Combining Chidamide and Azacitidine (VCA) regimen was applied to one 62-year-old male patient with AML who achieved CR. Meanwhile, Liposome mitoxantrone has better safety and tolerance than mitoxantrone in elderly patients. Thus, this study is intended to use 2 cycles of VCA regimens followed by 2 cycles of D-MAG regimens, and then repeat the above four courses of treatment once to improve the median event free survival of elderly AML patients.

VCA Regimen Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Venetoclax Combining Chidamide and Azacitidine (VCA) Regimen Followed by Dicitabine Combined With Liposome Mitoxantrone, Cytarabine, and G-CSF (D-MAG) Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) : A Multicenter, Prospective, Single Arm Clinical Trial

Leukemia-free survival (LFS) is defined as survival without evidence of relapse from treatment initiation

Overall survival（OS）is defined as the time from treatment initiation to death from any cause.

Adverse event is defined as any untoward medical occurrence associated with treatment

ORR is defined as CR, CRi and PR. Partial remission (PR) is defined as a decrease of at least 50% in the percentage of blasts to 5 to 25% in the bone marrow aspirate and the normalization of blood counts.

Chipscreen Biosciences, Ltd.

CSPC Pharmaceutical Group Limited

Fujian Provincial Hospital

Fujian Cancer Hospital

Zhangzhou manicipal hospital of Fujian Province

Jieyang People's Hospital

Huizhou Municipal Central Hospital

The First Affiliated Hospital of Xiamen University

Digestive System Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Micronutrients

Irinotecan

Leucovorin

Fluorouracil

Oxaliplatin

Topoisomerase I Inhibitors

IROX arm: FOLFIRI -\> FOLFOX

FOLFOX REGIMEN

D1 Oxaliplatin 85mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr

Every 2 weeks

FOLFILI REGIMEN

D1 Irinotecan 150mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr

OXIR arm: FOLFIRI -\> FOLFOX

FOLFOX REGIMEN

D1 Oxaliplatin 85mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr

Every 2 weeks

FOLFILI REGIMEN

D1 Irinotecan 150mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr

OXIR: FOLFOX -\> FOLFIRI

IROX: FOLFIRI -\> FOLFOX

FOLFOX REGIMEN

D1 Oxaliplatin 85mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr

Every 2 weeks

FOLFILI REGIMEN

D1 Irinotecan 150mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr

Every 2 weeks

irinotecan, oxaliplatin

FOLFOX REGIMEN

D1 Oxaliplatin 85mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr

Every 2 weeks

FOLFILI REGIMEN

D1 Irinotecan 150mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr

Every 2 weeks

oxaliplatin, irinotecan

HYUK-CHAN KWON, M.D.,Ph.D

FOLFOX\* followed by FOLFIRI\*\* or reverse sequence treatment regimen have been used as a standard treatment modality in metastatic colorectal cancer.Oxaliplatin and Irinotecan were used for advanced gastric cancer also. The investigators study was designed to evaluate the safety and efficacy of FOLFOX followed by FOLFIRI or reverse sequence treatment regimen as a first-line and second line therapy for patients with relapsed or metastatic gastric cancer similar with colorectal cancer.

\*FOLFOX: oxaliplatin followed by leucovorin before bolus 5-FU followed by continuous infusion 5-FU

\*\*FOLFIRI: irinotecan followed by leucovorin before bolus 5-FU followed by continuous infusion 5-FU

Gastric cancer remains a major public health issue, and is the fourth most common cancer and the second leading cause of cancer deaths worldwide. In Korea, gastric cancer is the most common cancer in men, the second most common cancer in women, and the second leading cause of cancer death. Despite the development of early gastric cancer detection programs, more than two-thirds of patients diagnosed with gastric cancer will develop unresectable disease. Even patients with operable tumors evidence high rates of both local and distant recurrence. In cases of advanced gastric cancer, the median survival rate is 9 to 10 months. Additionally, the overall 5-year survival rate is less than 25% in Korea and Japan.

Several combination regimens of chemotherapy for gastric cancer have been developed, but the survival advantage appears to be marginal, and no worldwide standard regimens have yet been established. Recently, a meta-analysis has been conducted to evaluate the efficacy and tolerability of chemotherapy in patients with advanced gastric cancer. The analysis of chemotherapy versus best supportive care (Hazard Ratio/HR = 0.39, confidence interval (CI) 95% 0.28-0.52) and combination versus single agent, mainly 5-Fluorouracil (5-FU), (HR = 0.83, 95% CI 0.74-0.93) demonstrated significant OS results in favour of chemotherapy and combination chemotherapy. Several chemotherapeutic drugs, including 5-fluorouracil (5-FU), mitomycin C, nitrosoureas, and doxorubicin have evidenced some level of efficacy against advanced gastric cancer. However, the majority of combination chemotherapy regimens for advanced gastric cancer have evidenced overall response rates in a range of 30 to 50% in phase II studies. Furthermore, no new regimens including the use of taxanes or irinotecan have improved either response or survivals in phase II or III trials other than docetaxel, cisplatina and infusional 5-FU (DCF) combination.

Oxaliplatin, a third-generation platinum analogue, is a diaminocyclohexane platinum which forms interstrand DNA adducts, which differ from those formed by cisplatin or carboplatin in terms of their capability to overcome resistance mechanisms. FOLFOX-4 or FOLFOX-6 combination regimen have demonstrated response rate of 38%-50% as a first-line treatment of gastric cancer.

Irinotecan (CPT-11,7-ethyl-10-\[4-(1-piperidino)-1-piperidino\] is a semi-synthetic plant alkaloid obtained from Camptotheca acuminate of the Nyssaceae family. After conversion to its active metabolite, SN-38, irinotecan acts by inhibiting the eukaryotic enzyme, DNA-topoisomerase I. Single-agent irinotecan has evidenced response rates of 13-23% in cases of advanced gastric cancer. 5-Fluorouracil (5-FU) and Topoisomerase I inhibitor-based regimens have demonstrated a response rate of 20-29%, and have been suggested as a first-line treatment for advanced gastric cancer.

FOLFOX followed by FOLFIRI or reverse sequence treatment regimen have been used as a standard treatment modality in metastatic colorectal cancer.

The study was designed to evaluate the safety and efficacy of FOLFOX followed by FOLFIRI or reverse sequence treatment regimen as a first-line and second line therapy for patients with relapsed or metastatic gastric cancer similar with colorectal cancer.

FOLFOX Followed by FOLFIRI or Reverse Sequence Treatment in Advanced Gastric Cancer (AGC)

Randomized Phase II Study of FOLFOX Followed by FOLFIRI or Reverse Sequence Treatment in Patients With Advanced or Relapsed Gastric Cancer

Pusan National University Yangsan Hospital

Dong-A University Hospital

Department of internal medicine

Gland and Hormone Related Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Pancreatic Cancer

Bone Density Conservation Agents

Vitamins

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Levoleucovorin

Calcium

Folfirinox

Calcium, Dietary

Folinic Acid

One cycle of sequential treatment lasts for 56 days.

1. Stage 1(28 days): AG regimen. Nab-paclitaxel (Abraxane) 125mg/m\^2 + gemcitabine 1000mg/m\^2 (days 1, 8, 15, 28)
2. Stage 2(28 days)：mFolfirinox regimen. Fluorouracil 2400 mg/m\^2 continuous intravenous drip 46h + calcium folinate 400 mg/m\^2 + irinotecan 135 mg/m\^2 + oxaliplatin 68 mg/m\^2 (day 1, 15, a total of 28 days).

Repeat the cycle above until progression or intolerance of toxicity.

One cycle of the treatment lasts for 56 days. Patients will receive chemotherapy based on Nab-paclitaxel Plus Gemcitabine and modified Folfirinox in sequence order. The cycle will repeat until progression or intolerance of toxicity.

Sequential Treatment

Tingbo Liang, MD PhD

Qi Zhang, MD

The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend Nab-paclitaxel, Gemcitabine and modified Folfirinox as the first-line chemotherapeutic regimen. Studies have shown that sequential chemotherapeutic regimen can effectively delay the drug resistance and improve the effect of chemotherapy. Here investigators intend to assess the effect of sequential treatment with Nab-paclitaxel plus Gemcitabine and modified Folfirinox on metastatic pancreatic adenocarcinoma.

Investigators chose metastatic pancreatic adenocarcinoma patients who can't meet surgical criteria. The planned treatment was given to the participants after enrollment. Objective remission rate, disease control rate, tumor size, progression-free survival, overall survival, drugs related side effects and other endpoints events were recorded and analyzed, to assess the sequential treatment with Nab-paclitaxel plus Gemcitabine and modified Folfirinox could or couldn't effectively control the progress of metastatic pancreatic adenocarcinoma.

Efficacy Evaluation of Sequential Treatment With AG and Modified Folfirinox in Metastatic Pancreatic Adenocarcinoma

Efficacy Evaluation of Sequential Treatment With Nab-paclitaxel Plus Gemcitabine and Modified Folfirinox in Metastatic Pancreatic Adenocarcinoma

The time of initial response until documented tumor progression.

The time of initial response until documented patient death.

Percentage of people does not get worse for a period of time after diagnosis

Percentage of patients whose cancer doesn't progress after treatment

Assessed by the European Organization for Research and Treatment of Cancer Quality of Life-pancreatic cancer 26 score(EORTC QLQ - PAN26)

According to Common Toxicity Criteria for Adverse Effects version 4

Second Affiliated Hospital, School of Medicine, Zhejiang University

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Mitomycins

Mitomycin

BCG Vaccine

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Intravesical sequential treatment of Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml

Intravesical sequential treatment of Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml.

Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml

Ho Kyung Seo, MD

Eui Hyun Jung, Ph.D

Ho Kyung Seo

The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients.

Phase 2 clinical, multi-institutional, open assignment prospective study

Primary Outcome Measures:

1-year recurrence-free survival period in high-risk groups after sequential injection of Mitomycin-c 40 mg/20 ml and Gemcitabine 2000 mg/50 ml in non-muscle invasive bladder cancer patients in BCG-free high-risk groups.

Secondary Outcome Measures:

Progression Free Survival (PFS), Cystectomy free survival (CFS), Cancer specific survival (CSS), Overall survival (OS) and safety after Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml treatment in non-muscle invasive bladder cancer patients in BCG-free high-risk groups.

The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy

A Study to Assess the Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy in Patients With High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to BCG Therapy

Defined as the time when bladder cancer recurrence was first confirmed by biopsy at the initial TURBT date\*, the time of disease progression (see PFS definition), the time of radical bladder resection, the time of bladder cancer metastasis, or the time of bladder cancer death.

defined as the period from the initial TURBT date\* to the time when T stage progresses (e.g., Ta\>T1, CIS\>T1) (PFS1) or muscle invasive bladder cancer (T2 or higher) was first biopsy confirmed (PFS2) or imagingally diagnosed with metastasis to bladder cancer.

Defined as the period from the initial TURBT date\* to the time when radical cystomy was performed.

Duration from initial TURBT date\* to the time of death from bladder cancer

The period from the initial TURBT date\* to the point of death (regardless of cause)

The first safety analysis is conducted on test subjects who have developed toxicity in accordance with CTCAE standards. In particular, urinary disorders such as urinary tract infections and acute urination that occurred after injection of drugs into the bladder are evaluated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
VCA Regimen Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)	NCT05603884	Leukemia, Myelo... AML Stage, Adul...	Venetoclax Comb...	60 Years -	The First Affiliated Hospital of Xiamen University
FOLFOX Followed by FOLFIRI or Reverse Sequence Treatment in Advanced Gastric Cancer (AGC)	NCT01138904	Gastric Cancer	irinotecan, oxa... oxaliplatin, ir...	20 Years -	Dong-A University Hospital
VCA Regimen Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)	NCT05603884	Leukemia, Myelo... AML Stage, Adul...	Venetoclax Comb...	60 Years -	The First Affiliated Hospital of Xiamen University
Efficacy Evaluation of Sequential Treatment With AG and Modified Folfirinox in Metastatic Pancreatic Adenocarcinoma	NCT03633734	Pancreatic Aden... Chemotherapy Ef...	Sequential Trea...	18 Years - 80 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
FOLFOX Followed by FOLFIRI or Reverse Sequence Treatment in Advanced Gastric Cancer (AGC)	NCT01138904	Gastric Cancer	irinotecan, oxa... oxaliplatin, ir...	20 Years -	Dong-A University Hospital
The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy	NCT06388720	Bladder Cancer	Mitomycin-c 40m...	20 Years -	National Cancer Center, Korea
FOLFOX Followed by FOLFIRI or Reverse Sequence Treatment in Advanced Gastric Cancer (AGC)	NCT01138904	Gastric Cancer	irinotecan, oxa... oxaliplatin, ir...	20 Years -	Dong-A University Hospital

Spots Global Cancer Trial Database for sequential treatment