Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Infections

Rare Diseases

Carcinoma

Atrophy

Stomach Neoplasms

Communicable Diseases

Gastritis, Atrophic

Gastritis

Gastroenteritis

Gastrointestinal Diseases

Stomach Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Stomach Cancer

Chronic Graft Versus Host Disease

Jian-Kun Hu, M.D. Ph.D.

Jian-Kun Hu

To establish prospective cohort of healthy population and corresponding serum sample bank in Sichuan province to provide platform for exploring early diagnosis and screening strategy of gastric cancer by a prospective cohort study.

H. pylori was one of the most important carcinogenic factor for gastric cancer and play a crucial role in inducing gastritis, atrophy and canceration. Chronic atrophic gastritis (CAG) was a common precancerous disease, people with CAG become high-risk population and need regular follow-up. However, study about occurrence risk prediction for gastric cancer when H. pylori infection concurrence with CAG was still spare. In especial, there was still no population screening program based on serology. The relative clinical epidemiology for providing evidence for China gastric cancer screening program was very rare.

This study aim to evaluate gastric cancer occurrence risk and diagnostic value of people combined with H. pylori infection and CAG by Serological methods in Sichuan province China. We also project to design optimized screening program suitable for people in sichuan province China.

Early Detection and Screening Strategy of Gatric Cancer in Sichuan Province-A Prospective Cohort Study (WCH-GC-SIGES-01)

A Prospective Cohort Study of Early Detection and Screening Strategy for Gatric Cancer in Sichuan Province China (SIGES-01)

The new cases of gastric and other epidermal malignant tumor

The time during SIGES when finding nee gastric cancer and relative disease

Xin-Zu Chen

Vice director of Gastrointestinal Surgery department, West China Hospital; Director of Institute of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital

Neoplasm Metastasis

Tissue Adhesions

Neoplasm Seeding

Neoplastic Processes

Biological: CAR-T cells targeting EpCAM Chemotherapy: determined by medical Oncologist

Chemotherapy: determined by medical Oncologist

CAR-T cells targeting EpCAM

Chemotherapy

To investigate the safety and efficacy of intraperitoneal infusion of EpCAM CAR-T cell in advanced gastric cancer with peritoneal metastasis by a prospective nonrandomized controlled trial.

Chimeric antigen receptor modified T (CAR-T) cells have the capability in targeting and recognizing tumor antigen, and can specifically recognize, bind and kill tumor cells with positive antigen. Through local drug delivery, CAR-T cells have successfully achieved remarkable effect to treat solid tumors. Gastric cancer is one of the most frequent malignant tumors with high mortality, especially in China. Peritoneal metastasis is one of the common routes of metastasis. Once peritoneal metastasis occurred, patients should be categorized as clinical pathological stage IV with extremely poor prognosis, and the effect of routine treatments would be unsatisfactory. Epithelial cell adhesion molecule (EpCAM) is highly expressed in gastric cancer cells and closely associated with the poor prognosis of patients. In our previous pre-clinical research researches, the investigators have obtained CAR-T cells targeting EpCAM (EpCAM CAR-T), and finished the preparations of cells which could be used in clinical practice. Based on our previous works, the investigators aim to investigate the safety and efficacy of peritoneal infusion of EpCAM CAR-T cell in advanced gastric cancer with peritoneal metastasis by a prospective nonrandomized controlled trial. The results of this clinical trial are expected to provide the new treatment strategy for gastric cancer patients with peritoneal metastasis.

Intraperitoneal Infusion of EpCAM CAR-T Cell in Advanced Gastric Cancer With Peritoneal Metastasis (WCH-GC-CART)

Clinical Trial of Intraperitoneal CAR-T Cells Infusion for the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis

Adverse events after receiving EpCAM CAR-T cells treatment, according to NCI-CTCAE v4.0.

The level of CAR-T cells will be tested regularly by Real-time Quantitative Polymerase Chain Reaction Detecting System(qPCR) or Flow cytometry.

Colorectal Neoplasms

Esophageal Neoplasms

Duodenal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Head and Neck Neoplasms

Esophageal Diseases

Duodenal Diseases

Esophageal Cancer

Endoscopic injection of fluid into the gastrointestinal submucosal space followed by endoscopic knife dissection around and under the lesion so as to remove the lesion specimen in one piece with lesion free resection margins.

Endoscopic submucosal dissection (ESD)

Ciocirlan L Mihai, Associate Professor

Mihai L Ciocirlan

Mihai L Ciocirlan, Associate Professor

This is a patient registry for all cases of pre-neoplastic or early neoplastic digestive tract lesions treated with curative intention by endoscopic submucosal dissection (ESD) technique.

Cases will be registered one by one in an electronic record, with the consent of the patient and respecting all legal requirements.

Resected specimens of the gastrointestinal tract, fixed in formalin

Endoscopic Submucosal Dissection Registry

Endoscopic Submucosal Dissection Patients Registry in "Agrippa Ionescu" Hospital, Bucharest, Romania

Carol Davila University of Medicine and Pharmacy

Clinical Professor (Associate Professor)

Blood and Lymph Conditions

Gland and Hormone Related Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Pancreatic Neoplasms

Recurrence

Acute Disease

Neoplasms by Histologic Type

Hematologic Diseases

Disease Attributes

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Pancreatic Cancer

Acute Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Gastrointestinal Agents

All Drugs and Chemicals

Herbal and Botanical

Pancrelipase

Pancreatin

Cola

Patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and bile ducts) and newly diagnosed/relapse acute leukemias who meet the inclusion criteria will take the anamu extract with chemotherapy to evaluate the adverse drug-related side effects.

For solid metastatic tumors, 30 patients will be recruited, which can be from the colon, pancreas, stomach, and bile ducts, divided into two groups of 15 patients, an intervention group and a placebo group. The intervention group will receive the Esperanza extract at DMT for three continuous treatment cycles (approximately 12 weeks), and the other group will receive the placebo.

For solid metastatic tumors, 30 patients will be recruited, which can be from the colon, pancreas, stomach, and bile ducts, divided into two groups of 15 patients, an intervention group and a placebo group. The intervention group will receive the Esperanza extract at DMT for three continuous treatment cycles (approximately 12 weeks), and the other group will receive the placebo. Both groups will receive standard chemotherapy treatment for their underlying disease. The safety evaluation will be carried out in each treatment cycle, and the efficacy evaluation will be carried out at the end of the three cycles.

For newly diagnosed hematological tumors, 28 patients will be recruited and will receive the Esperanza extract at DMT. The intervention group will continuously receive the Esperanza extract at DMT for four weeks with the standard chemotherapy regimen for their underlying disease. The safety and efficacy evaluation will be carried out at the end of the treatment cycle.

Patients with relapsed or refractory acute leukemias will be admitted to receive the calculated DMT in phase Ib; A total of 6 patients will be recruited, and safety and efficacy evaluations will be performed during three treatment cycles or progression and death of the patient.

For the analysis of the response in patients with acute leukemia, a comparison will be made with a group followed historically. A propensity score matching will be performed for statistical analysis in case of differences in their baseline characteristics.

Petiveria Alliacea Preparation

Placebo

This is a phase Ib/II clinical study that has two phases. In phase Ib, the safety evaluation of the extract of Petiveria alliacea (Esperanza) will be carried out in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) and patients with newly diagnosed and relapsed acute leukemia. In phase IIb, the safety will continue to be evaluated, and the efficacy of the Esperanza extract will be explored in combination with chemotherapy in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) with newly diagnosed acute leukemias and relapses.

Anamú, Petiveria alliacea, has been used by traditional medicine to treat leukemia and breast cancer. However, its activity on tumor metabolism makes it a therapeutic candidate for many tumors with alterations in glycolytic metabolism, but also uses the mitochondria to produce energy.

Given the glycolytic nature of some tumor cells, the modulating activity of cell metabolism exerted by anamú extract may be partly responsible for the anti-tumor activity.

Previous reports show that some patients with ALL or AML whose response to treatment was evaluated in vitro are sensitive to a standardized extract of Petiveria alliacea. Even more interesting is the fact that when we treat the cells with allopathic therapy, explicitly established for each of these pathologies, the sensitivity of the blasts increases when they are treated concomitantly with the extract, which suggests that the intrinsic resistance of each one of tumor cells in the different tissues evaluated can be reduced by the action of the phytomedicine. The same thing was observed when spheres obtained from human breast cancer were co-treated with the anamú extract and anthracyclines. These observations allow to validate the traditional use of anamú in the treatment of some tumors, such as leukemia and breast cancer, among others. However, to observe the safety and effects on patients, it is necessary to develop a clinical study that would allow the anamú phytomedicine produced in the appropriate pharmaceutical conditions, to be included as a complementary therapy based on a standardized extract of the plant and that can overcome the resistance of tumor cells to conventional treatments, improving response and increasing overall survival of patients in Colombia.

Although the explosion of new therapies in solid tumors and hematological alterations is not so high, countries such as Germany, France, and Italy have used traditional medicine from which herbal pharmaceutical preparations are derived in the treatment of different types of diseases, including cancer. , estimating the use of these products between 30 and 75% of patients worldwide. These herbal products are mainly used to reduce allopathic therapies' side effects and organic toxicity, protect and stimulate the immune system, or prevent future neoplasms or their recurrence. Currently, various extracts from natural products are in clinical trials in the United States, and there is significant evidence about some plants' role in leukemia's evolution.

This is a phase Ib/II clinical study that has two phases. In phase Ib, the safety evaluation of the extract of Petiveria alliacea (Esperanza) will be carried out in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) and patients with newly diagnosed and relapsed acute leukemia. In phase IIb, the safety will continue to be evaluated, and the efficacy of the Esperanza extract will be explored in combination with chemotherapy in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and biliary tract) with newly diagnosed acute leukemias and relapses.

This is a phase Ib/II clinical study that has two phases. In phase Ib, the safety evaluation of the extract of Petiveria alliacea (Esperanza) will be carried out in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach and biliary tract) and patients with newly diagnosed and relapsed acute leukemia. In phase IIb, the safety will continue to be evaluated and the efficacy of the Esperanza extract will be explored in combination with chemotherapy in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach and biliary tract) and patients with newly diagnosed acute leukemias and relapses

At the screening visit, all subjects will be randomly assigned a unique subject number (e.g., 001,002,003, etc.). Enrolled subjects will retain the subject number assigned at Screening Visit throughout the study. In phase Ib, no randomization will be performed. All subjects will receive the therapy chosen by the treating physician.

Patients enrolled in phase II will be randomized through the application built in the eCRF in RedCap® for this purpose. Participant, care provider and Investigator will be blind.

Evaluation of the Safety and Efficacy of Esperanza Extract (PA001)

Evaluation of the Safety and Efficacy of Esperanza Extract (Petiveria Alliacea) in Patients With Metastatic Gastrointestinal Tumors and Acute Leukemia

Evaluate the adverse drug reactions of cancer patients treated with anamú extract and chemotherapy through the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

Changes of at least 5 points above the difference between the groups of the functional scales of the patients evaluated using the EORTC QLQ-C-30 scale

To determine the impact of treatment with Esperanza extract in combination with chemotherapy on the number and size of metastases.

To determine event/progression-free survival in patients with metastatic gastrointestinal tumors (colon, pancreas, stomach, and bile ducts) and patients with newly diagnosed and relapsed acute leukemias.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Early Detection and Screening Strategy of Gatric Cancer in Sichuan Province-A Prospective Cohort Study (WCH-GC-SIGES-01)	NCT03597672	Neoplasm, Stoma... H. Pylori Infec... Chronic Atrophi...		20 Years - 70 Years	West China Hospital
Intraperitoneal Infusion of EpCAM CAR-T Cell in Advanced Gastric Cancer With Peritoneal Metastasis (WCH-GC-CART)	NCT03563326	Neoplasm, Stoma... Metastases, Neo... Neoplasm Seedin...	CAR-T cells tar... Chemotherapy	18 Years - 75 Years	West China Hospital
Endoscopic Submucosal Dissection Registry	NCT06033976	Neoplasm, Stoma... Neoplasm, Color... Neoplasm, Esoph... Neoplasm, Duode...	Endoscopic subm...	18 Years - 100 Years	Carol Davila University of Medicine and Pharmacy
Evaluation of the Safety and Efficacy of Esperanza Extract (PA001)	NCT05587088	Neoplasm, Stoma... Gastric Neoplas... Pancreatic Neop... Colorectal Neop... Acute Leukemia Acute Leukemia ... Acute Leukemia ... Acute Myeloid L... Acute Myeloid L...	Petiveria Allia... Placebo	18 Years - 99 Years	Hospital Universitario San Ignacio
Early Detection and Screening Strategy of Gatric Cancer in Sichuan Province-A Prospective Cohort Study (WCH-GC-SIGES-01)	NCT03597672	Neoplasm, Stoma... H. Pylori Infec... Chronic Atrophi...		20 Years - 70 Years	West China Hospital

Spots Global Cancer Trial Database for neoplasm, stomach