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NCT ID: NCT04682028 Recruiting - Surgical Stomas Clinical Trials

Construction and Evaluation of a Stoma Patient Continuous Care Network

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

Construct a professional network platformof continuous care for patients with enterostomy and evaluate its availability, Eventually, patients with enterostomy will have access to care outside the hospital.

NCT ID: NCT04681911 Recruiting - Breast Cancer Clinical Trials

Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer

Start date: September 9, 2020
Phase: Phase 2
Study type: Interventional

HER2-targeted therapy after the failure of trastuzumab treatment has become a new difficulty and challenge. Inetetamab, a new antibody to optimize the ADCC effect, has become one of the second-line treatment options after trastuzumab fails, showing good survival benefits. Pyrotinib, another second-line HER2 targeted drug, is a typical representative of TKI drugs, which not only has a strong HER2 antagonistic effect but also can synergize with monoclonal antibodies to amplify the ADCC effect. Pyrotinib and Inetetamab showed excellent anti-tumor efficacy and good safety in TKI and optimized ADCC respectively. we plan to carry out a phase II single-arm clinical study to evaluate the efficacy and safety of "Inetetamab combined with Pyrotinib and chemotherapy" in the treatment of her positive metastatic breast cancer.

NCT ID: NCT04681820 Recruiting - Clinical trials for CML-CP; Mutation;Suboptimal Response or Failure in TKI

Evaluating Efficacy and Safety of Flumatinib for Chronic Phase Chronic Myeloid Leukemia(CML-CP) Without Optimal Response (Warning,Failure) to Imatinib or Dasatinib

Start date: November 1, 2020
Phase:
Study type: Observational

Imatinib has revolutionized the treatment of chronic myeloid leukemia (CML) and is the current standard of care in the treatment of patients with newly diagnosed CML. However, about 30% of patients still show drug resistance or disease progression. Currently, the most widely studied mechanism of TKI resistance in CML patients is mutations in the ABL kinase region. So far, more than 100 kinase domain mutations have been found in disease progression and imatinib resistance. It is estimated that more than 25% of CML patients will change TKI at least once in their lifetime due to drug resistance or intolerance. The 2020 edition of the "Guidelines for the Diagnosis and Treatment of Chronic Myelogenous Leukemia in China" proposes that patients with F317L/V/I/C, V299L and T315A mutations are more likely to obtain clinical efficacy by switching to the second-generation TKI nilotinib; patients with Y253H, E255K/V and F359C/V/I mutations are more likely to obtain clinical efficacy by switching to the second-generation TKI dasatinib; patients with T315I mutations are resistant to both nilotinib and dasatinib. Flumatinib has been shown to be a more potent inhibitor of BCR-ABL1 tyrosine kinase than imatinib. In vitro studies, it has shown that flumatinib inhibits wild-type and common BCR-ABL mutations(Q252H, V299L, F317L/I, M351T, H396P, etc.) more potently, and the anti-mutation spectrum of flumatinib is similar to nilotinib. Therefore, this study is designed to provide clearer guidance for patients with suboptimal response or failure in the treatment of TKI as well as those who have specific ABL kinase domain mutations during CML treatment.

NCT ID: NCT04680598 Recruiting - Clinical trials for Hepatocellular Carcinoma

Comparison of HBV Reactivation Between Patients With High HBV-DNA and Low HBV-DNA Loads Undergoing ICI and Concurrent Antiviral Prophylaxis: a Prospective Observational Study

Start date: December 25, 2020
Phase:
Study type: Observational

Immune checkpoint inhibitor (ICI), including programmed cell death protein-1 (PD-1) inhibitor or programmed cell death-Ligand 1 (PD-L1) inhibitor , is recommended to treat advanced hepatocellular carcinoma (HCC). However, the safety of ICI in patients with a high HBV-DNA load is unknown because of the potential risk of hepatitis B virus (HBV) reactivation. This study was to compare the HBV reactivation between patients with low HBV-DNA loads and high HBV-DNA loads undergoing antiviral prophylaxis and ICI.

NCT ID: NCT04679038 Recruiting - Solid Tumor Clinical Trials

A Trial of SHR-1701 in Combination With Famitinib in Patients With Advanced Solid Tumors

Start date: March 17, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, multi-center study to evaluate the efficacy and safety of SHR-1701 in combination with famitinib in subjects with metastatic or locally advanced solid tumor. There are two parts of the study: combinational therapy part and monotherapy part. Phase I of combinational therapy part is to determine the recommended dose for Phase II (RP2D) for famitinib in the combined regimen, then efficacy and safety of SHR-1701 plus famitinib (RP2D) will be further evaluated in the following Phase II in cohorts 1/2/3, with simon's two-stage design. Meanwhile, efficacy and safety of famitinib will also be assessed in cohorts 4/5 in the monotherapy part.

NCT ID: NCT04678908 Recruiting - Tumor, Subjects Clinical Trials

A Study of Injection HB0025 in Patients With Advanced Solid Tumors

Start date: March 10, 2021
Phase: Phase 1
Study type: Interventional

This is a multicenter, open-label, dose escalation and expansion study. During the study, subjects will be evaluated for safety, toxicity, tolerability, PK/PD, immunogenicity, biomarkers, and antitumor activity of HB0025. The phase I study will enroll up to 154 subjects with advanced solid tumors who have progressed on or after standard of care therapy and for whom there is no further treatment available that in the judgement of the patient's physician would be beneficial. One cycle is defined as 28 days.

NCT ID: NCT04677868 Recruiting - Acute GVH Disease Clinical Trials

MTX and Steroid for aGVHD Treatment

Start date: December 23, 2020
Phase: Phase 2
Study type: Interventional

The aim of the study is to identify the efficacy and safety of methotrexate (MTX) combined corticosteroid treatment for acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT).

NCT ID: NCT04677452 Recruiting - Safety and Efficacy Clinical Trials

Dose Exploration Study OF JWCAR129, BCMA-Targeted CART for RRMM

Start date: December 2020
Phase: Phase 1
Study type: Interventional

This is an open-label, Phase 1 dose exploration study to evaluate the safety and tolerability and to determine recommended Phase 2 dose(s) of JWCAR129, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed and/or refractory multiple myeloma.

NCT ID: NCT04677439 Recruiting - Clinical trials for Chronic Myeloid Leukemia, Chronic Phase

Flumatinib in CML-CP Patients With Ph+ Post Imatinib Failure

Start date: January 1, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to explore the efficacy and safety of flumatinib in chronic phase of chronic myeloid leukemia (CML-CP) patients With Ph+ post imatinib failure.

NCT ID: NCT04676997 Recruiting - Clinical trials for Triple Negative Breast Cancer

Neoadjuvant Study of Camrelizumab Plus Chemotherapy in Triple Negative Breast Cancer (TNBC)

Start date: May 20, 2020
Phase: Phase 2
Study type: Interventional

The study is being conducted to evaluate the efficacy, safety and tolerability of Camrelizumab Combination With Nab-Paclitaxel and Epirubicin as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)