Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Tislelizumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Surgery was evaluated after chemoradiotherapy (40-41.4Gy/1.8-2Gy/20-23 fractions) followed by two cycles of chemotherapy and immunotherapy

Surgery was evaluated after two cycles of chemotherapy and immunotherapy followed by chemoradiotherapy(40-41.4Gy/1.8-2Gy/20-23 fractions)

Surgery was evaluated after concurrent definitive chemoradiotherapy (50-50.4Gy/1.8-2Gy/25-28fractions) and immunotherapy.

Different sequences and methods of treatment to convert surgery

Tislelizumab (BGB-A317) with chemoradiotherapy

Xin Wang, Doctor

Ziyu Zheng, B.M

Xin Wang, MD

Patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) that is deemed unresectable face a bleak prognosis. Recent phase 1/2 studies have demonstrated the efficacy and safety of augmenting neoadjuvant concurrent chemoradiotherapy with immunotherapy in treating resectable ESCC. The present study is a prospective, 3-arm, randomized trial that seeks to evaluate the efficacy of diverse conversion therapy modalities in patients with unresectable ESCC. The study objectives include R0 resection rate, treatment-related adverse events, morbidity and mortality, 1-year progression-free survival (PFS), and 1-year overall survival (OS) rates.

Tislelizumab is a humanized IgG4 monoclonal antibody with high affinity/specificity for programmed cell death protein 1 (PD-1). Tislelizumab was specifically engineered to minimize binding to FcɤR on macrophages, thereby abrogating antibody-dependent phagocytosis, a potential mechanism of T-cell clearance and resistance to anti-PD-1 therapy.

This trial will provide valuable insights into the effectiveness of the three conversion therapy modalities and help to inform clinical decision-making for patients with unresectable locally advanced ESCC.

Neoadjuvant Comprehensive Treatment for Unresectable Esophageal Cancer

NEoadjuvant Total rX for Borderline Unresectable Esophageal Squamous Cell Carcinoma: a Prospective Randomized, Three-Arm, Open-Label Phase II Trial (NEXUS-2)

Minimal distance tumor/circumferential resection margin (CRM) \> 1 mm.

Defined as the proportion of patients still alive within one year from treatment initiation.

Defined as the proportion of patients without disease progression or death within one year from treatment initiation.

To investigate whether ctDNA variation can be used for MRD monitoring in patients with unresectable locally advanced ESCC.

Adverse event during chemoRT or immunotherapy

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Principal Investigator

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Palliative chemotherapy followed by radical gastrectomy

Conversion surgery

This study aims to identify the safety and the survival benefit of the conversion surgery in stage IV or unresectable gastric cancer. The study designed single-arm phase II trial. All the patients would undergo curative-intent radical gastrectomy after palliative chemotherapy if the tumor responded to the chemotherapy. Primary endpoint was three-year overall survival. Secondary endpoints included short-term postoperative outcomes within 30 days, three-year relapse free survival, and success rate of conversion surgery (rate of R0 resection).

The survival rate of patients with stage IV gastric cancer (GC) is very low. Recently, several retrospective studies about conversion surgery have been introduced. The results of the studies showed around 30\~40% of three-year survival rate in conversion surgery group. Eight institutions in Catholic University of Korea analyzed 419 stage IV GC patients, and they had divided into four groups: chemotherapy only, chemotherapy followed by gastrectomy, gastrectomy followed by chemotherapy, and best supportive care group. The group of gastrectomy followed by chemotherapy, which is similar with conversion surgery, showed 40% of three-year survival rate. However, the study included only small number of patients who were in conversion surgery group, and had several biases. Thus, we planned multi-national, multi-center phase II trial for conversion surgery in stage IV or unresectable GC.

Conversion Surgery in Stage IV or Unresectable Gastric Cancer

The Multi-national Multi-institutional Phase 2 Trial for Conversion Surgery in Stage IV or Unresectable Gastric Cancer

3-year overall survival after conversion surgery

Short-term complication rate after conversion surgery

3-year disease free survival after conversion surgery

The Catholic University of Korea

Peking University

Cho Hyun Park

Professor

Apatinib

Oxaliplatin

Protein Kinase Inhibitors

Enzyme Inhibitors

1. Apatinib :

   A starting dose of apatinib was administered 500 mg daily on days 1 through 21 of each 3-week cycle.
2. Oxaliplatin:130 mg/m2，d1，ivgtt，in a 21 day cycle.
3. S-1:40mg，bid，d1-14，po，in a 21 day cycle.

Apatinib :A starting dose of apatinib was administered 500 mg daily

Oxaliplatin:130 mg/m2，d1，ivgtt，in a 21 day cycle

S-1:40mg，bid，d1-14，po，in a 21 day cycle.

Hongqing Xi, Master

Lin Chen, Master

Lin Chen

This is a Prospective，Single-center，Single-arm，Open-label exploratory clinical trial evaluating the efficacy and safety of Conversion Surgery for Apatinib plus SOX for patients with unresectable gastric cancer.

Gastric cancer is the second most common cause of cancer-related deaths worldwide, and surgical resection during the early stage has improved treatment outcomes.However, many patients are diagnosed with unresectable advanced or metastatic stage disease losing the radical surgery opportunity. Systemic chemotherapy is the leading treatment that prolongs survival times for such patients.

Approximate 20 patients with unresectable gastric cancer will be enrolled in this study,the investigators will evaluate the efficacy and security of Apatinib + SOX(oxaliplatin+S-1) for unresectable gastric cancer.

The Study of Conversion Surgery for Apatinib in Combination With SOX for Patients With Unresectable Gastric Cancer

The Exploratory Study of Conversion Surgery for Apatinib in Combination With Oxaliplatin/S-1(SOX) for Patients With Unresectable Gastric Cancer

Chinese PLA General Hospital

Director of the General Surgery Department, Chinese PLA General Hospital

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Folfirinox

LAPC patients were enrolled prospectively and diagnosed by MDT group in our hospital. These patients further received the neoadjuvant therapy with mFOLFIRINOX, the Overall survival, Progression survival, response to mFOLFIRINOX, chemo-related Toxicities, Postoperative complications and Histopathologic staging were measured.

LAPC patients with mFOLFIRINOX-based neoadjuvant therapy or not was set as the main intervention

modified-FOLFIRINOX

FOLFIRINOX regimen is first-line neoadjuvant chemotherapies for patients with locally advanced pancreatic cancer (LAPC) worldwide. However, FOLFIRINOX is not well accepted in China because of the high prevalence of adverse events and poor tolerance. To evaluate the safety and efficacy of modified-FOLFIRINOX (mFOLFIRINOX) in Chinese LAPC patients and compare survival between LAPC patients with mFOLFIRINOX-based preoperative therapy and LAPC patients who underwent surgery alone.

At this institution, a mFOLFIRINOX regimen has been adopted for metastatic pancreatic cancer (MPC) patients and promising results obtained. The modification resulted in a significantly reduced prevalence of severe adverse events in MPC patients, whereas the OS and PFS were extended to 10.3m and 7.0m, respectively, which is similar to that for patients on a full-dose regimen. Therefore, the investigators further evaluated the efficacy of mFOLFIRINOX in LAPC patients. Here, investigators want to prospectively enroll LAPC patients who underwent preoperative therapy with mFOLFIRINOX from April 2014 and compared the surgical resectability and surgical morbidity/surgical mortality among patients with surgically resectable pancreatic cancer (RPC) or LAPC who underwent surgery alone retrospectively. For patients with LAPC, mFOLFIRINOX was administrated for several cycles until the optimal response was obtained and then patients were evaluated for surgery. Moreover, survival data, including OS and PFS, were determined.

Modified-FOLFIRINOX Regimen Based Neoadjuvant Therapy in Chinese Patients With Locally Advanced Pancreatic Cancer

the duration from the date of hospital admission to death of any cause.

the duration from the date of hospital admission to disease progression or death.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Symptoms and General Pathology

Adenocarcinoma

Neoplasm Metastasis

Peritoneal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Abdominal Neoplasms

Peritoneal Diseases

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Intraperitoneal chemotherapy in gastric cancer patients with peritoneal carcinomatosis.

Patients will undergo intraperitoneal chemotherapy with Paclitaxel (4 cycles) associated with systemic chemotherapy. After treatment, patients will be reassessed and if there is a peritoneal response, they will undergo gastrectomy

Intraperitoneal chemotherapy

Andre Roncon Dias, MD, PhD

Ulysses Ribeiro Jr, MD, PhD

Marcus Fernando Kodama Pertille Ramos, MD, PhD

Amir Zeide Charruf, MD

Marina Alessandra Pereira, MSc

Peritoneal carcinomatosis (PC) in gastric cancer (GC) is considered a fatal disease, without expectation of definitive cure. Since conventional surgery is not indicated in the palliative setting, and systemic chemotherapy treatments are not sufficient to contain the disease, a multimodal approach associating intraperitoneal (IP) chemotherapy (CMT) with surgery may represent an alternative for these patients.

IP CMT has shown superior results to conventional treatment in patients at this stage of the disease, and can achieve complete regression of lesions in a significant portion of cases. Once response to treatment is achieved, patients become fit for curative surgery, which offers a new perspective on the survival in these previously unresectable cases, and raising survival rates to similar levels to patients undergoing surgery with curative intention.

Thus, the aim of this study is to evaluate the complete response rate and curative resection in patients with PC by GC at Instituto do Cancer do Estado de São Paulo (ICESP) treated with IP CMT. Patients prospectively included in the study will undergo implantation of a peritoneum catheter to perform outpatient IP CMT in order to promote the regression of lesions. Those with complete regression may be referred for surgical treatment, curing a portion of these patients. The diagnosis of PC will be performed by conventional cytological, immunohistochemical and liquid cytology methods to determine the presence of tumor cells in the peritoneal lavage and to evaluate the sensitivity of the methods. In addition, it is proposed in the study the storage of material for further study of circulating markers in peripheral blood and peritoneal lavage that may be related to response or resistance to treatment.

It is believed that IP CMT may not only increase the survival of patients with PC, but also offer the possibility of cure for a significant portion of patients who are currently without treatment prospects and with a median survival of only six months.

This is a prospective study lasting 36 months.

Patients will undergo intraperitoneal chemotherapy with Paclitaxel (4 cycles) associated with systemic chemotherapy. After treatment, patients will be reassessed and if there is a peritoneal response, they will undergo gastrectomy.

Intraperitoneal Chemotherapy in Gastric Cancer With Peritoneal Carcinomatosis

Evaluation of Intraperitoneal Chemotherapy in the Treatment of Gastric Cancer in Patients With Peritoneal Carcinomatosis

Absence of visible carcinomatosis on imaging tests, absence of viable peritoneal lesion at laparoscopy and absence of neoplastic cells in peritoneal lavage.

Time between conversion surgery and date of disease progression, assessed in the first 6 months

Time between conversion surgery and last follow-up after 5 years

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant Comprehensive Treatment for Unresectable Esophageal Cancer	NCT06430658	Esophagus Cance...	Tislelizumab (B...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conversion Surgery in Stage IV or Unresectable Gastric Cancer	NCT03366961	Stage IV or Unr...	Conversion surg...	19 Years - 80 Years	Seoul St. Mary's Hospital
The Study of Conversion Surgery for Apatinib in Combination With SOX for Patients With Unresectable Gastric Cancer	NCT03007446	Gastric Cancer	Apatinib Oxaliplatin S-1	18 Years - 70 Years	Chinese PLA General Hospital
Modified-FOLFIRINOX Regimen Based Neoadjuvant Therapy in Chinese Patients With Locally Advanced Pancreatic Cancer	NCT03469375	Pancreatic Canc... Chemotherapy Ef... Surgery--Compli...	modified-FOLFIR...	18 Years - 85 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
The Study of Conversion Surgery for Apatinib in Combination With SOX for Patients With Unresectable Gastric Cancer	NCT03007446	Gastric Cancer	Apatinib Oxaliplatin S-1	18 Years - 70 Years	Chinese PLA General Hospital
Modified-FOLFIRINOX Regimen Based Neoadjuvant Therapy in Chinese Patients With Locally Advanced Pancreatic Cancer	NCT03469375	Pancreatic Canc... Chemotherapy Ef... Surgery--Compli...	modified-FOLFIR...	18 Years - 85 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
Intraperitoneal Chemotherapy in Gastric Cancer With Peritoneal Carcinomatosis	NCT05541146	Gastric Cancer Peritoneal Carc...	Intraperitoneal...	18 Years - 75 Years	Instituto do Cancer do Estado de São Paulo

Spots Global Cancer Trial Database for conversion surgery