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First-line Treatment clinical trials

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NCT ID: NCT06278870 Recruiting - Clinical trials for HER2-positive Metastatic Breast Cancer

Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial

Start date: September 6, 2023
Phase: Phase 3
Study type: Interventional

The goal of this multicentre, randomized, double-blind controlled, phase III clinical trial is to compare the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab (THP) for newly diagnosed recurrent/metastatic Human epidermal growth factor receptor 2 (HER2) positive advanced breast cancer, and to explore the impact of biomarkers on clinical efficacy and safety. The main questions it aims to answer are: - Analyse the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of THP. - Explore the impact of biomarkers on clinical efficacy and safety of the combination of disitamab vedotin in combination with pyrotinib treatment. Participants in the experimental group will receive disitamab vedotin in combination with pyrotinib for 6-8 cycles (each cycle lasting 28 days), followed by maintenance treatment with trastuzumab in combination with pyrotinib. Participants in the control group will receive paclitaxel in combination with trastuzumab and pertuzumab for 6-8 cycles (each cycle lasting 21 days), followed by maintenance treatment with trastuzumab and pertuzumab. Researchers will compare disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab to see if disitamab vedotin in combination with pyrotinib could be a new option for first-line treatment of HER2-positive metastatic breast cancer.

NCT ID: NCT06148779 Recruiting - Osteoarthritis Clinical Trials

Can Digitally Delivered First-line Osteoarthritis Treatment Improve Equal Access to Care

Access
Start date: January 1, 2022
Phase:
Study type: Observational

To improve chronically ill patients' health and quality of life, long-standing and continuous treatment is needed at an acceptable cost. The purpose of this study was to compare utilization of digital versus face-to-face delivered osteoarthritis (OA) treatment in the 21 different county councils of Sweden that are responsible for providing healthcare to the residents.

NCT ID: NCT05913661 Recruiting - Carcinoma Clinical Trials

Pemigatinib Combined With PD-1 Inhibitor in Unresectable or Metastatic Intrahepatic Cholangiocarcinoma

Start date: July 2023
Phase: Phase 2
Study type: Interventional

This is a Prospective, single-arm, phase II study with multicenter participation. The objective of this study is to evaluate the efficacy and safety of pemigatinib combined with PD-1 inhibitor as first-line treatment for patients with advanced unresectable or metastatic intrahepatic cholangiocarcinoma.

NCT ID: NCT05760053 Recruiting - Clinical trials for First-line Treatment

Toripalimab Plus Etoposide and Platinum-based Chemotherapy for Genitourinary Small Cell Carcinoma

Start date: February 18, 2023
Phase: Phase 2
Study type: Interventional

This study is a prospective, multicenter, open-label, single-arm phase II clinical trial. A single-arm experimental group of toripalimab, etoposide, and cisplatin/carboplatin was designed to evaluate its efficacy and safety in small cell carcinoma of the urinary system.

NCT ID: NCT05256472 Recruiting - Clinical trials for Renal Cell Carcinoma

A Study of AK104 Monotherapy or AK104 Plus Axitinib in Advanced/Metastatic Renal Cell Carcinoma

Start date: July 6, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase II, open-label trial to evaluate the efficacy and safety of AK104 monotherapy or AK104 in combination with axitinib as a first-line treatment for advanced/metastatic renal cell carcinoma (RCC). There are two parts in this trial. In part 1 of this study, subjects with unresectable advanced clear cell or non-clear cell renal cell carcinoma (ccRCC or nccRCC) who had not received systemic therapy for advanced disease will be enrolled to randomly received three different dosage of AK104 monotherapy. In part 2 of this study, subjects with unresectable advanced clear cell renal cell carcinoma (ccRCC) who had not received systemic therapy for advanced disease will be enrolled to receive AK104 plus Axitinib. All subjects will receive treatment until disease progression, development of unacceptable toxicity, death, a decision by the physician or patient to withdraw from the trial. The primary endpoint is ORR per RECIST v1.1 as assessed by investigators.

NCT ID: NCT05221775 Recruiting - Clinical trials for Advanced Gastric Carcinoma

Safety of XELOX Combined With GLS-010 and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients

Start date: November 1, 2021
Phase: Phase 1
Study type: Interventional

This is a single center, prospective, open label phase I study evaluating the safety and tolerance of standard first-line chemotherapy XELOX regimen combined with GLS-010 (anti-PD-1 antibody) and different doses of Lenvatinib in the treatment of advanced AFP-positive gastric cancer. This study was conducted in the Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute and Hospital. In this study, patients with AFP-positive and HER-2-negative advanced gastric cancer who had not received palliative systematic treatment in the past will be enrolled. Patients who met the inclusion criteria were treated with XELOX regimen combined with GLS-010 plus Lenvatinib every 3 weeks until disease progression or intolerable adverse reactions or death. The treatment regimen is XELOX chemotherapy (oxaliplatin 130mg/ m2, d1, capecitabine 850-1250 mg/m2, bid, d1-14, every 3 weeks) in combination with GLS-010 (240 mg, intravenous infusion, every 3 weeks) plus Lenvatinib whose dose is based on the '3 + 3' dose climbing mode (12mg, 16mg and 20mg respectively, orally once a day). Safety will be evaluated by AE and laboratory tests. Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.

NCT ID: NCT05077839 Recruiting - Clinical trials for Advanced Colorectal Cancer

Trifluridine/Tipiracil Combined With Oxaliplatin and Bevacizumab Versus XELOX Plus Bevacizumab in mCRC

TOBACO
Start date: September 1, 2021
Phase: Phase 2
Study type: Interventional

This is a two-group, parallel, randomized, standard-control phase II study comparing the safety and efficacy of trifluridine/tipiracil combined with oxaliplatin and bevacizumab versus XELOX plus bevacizumab in the first-line treatment of advanced colorectal cancer. This study was conducted in the Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute and Hospital. Patients with advanced colorectal cancer will be randomly assigned (1:1) to trifluridine/tipiracil combined with oxaliplatin and bevacizumab (experimental group) or XELOX plus bevacizumab (control group) after signing informed consent. In this study, 184 patients will be enrolled, 92 patients will receive trifluridine/tipiracil combined with oxaliplatin and bevacizumab and 92 patients will receive standard therapy. In the experimental group, the treatment regimen is trifluridine/tipiracil 35mg/m2 orally taken on d1-5 and d8-12, oxaliplatin 85mg/m2 and bevacizumab 5mg/kg intravenously infused on d1 and d15 every 4 weeks, up to 6 cycles. Then patients will be given trifluridine/tipiracil and bevacizumab maintenance treatment. Patients enrolled in this group could acquire trifluridine/tipiracil free of charge. The control group was XELOX plus bevacizumab regimen, bevacizumab 7.5mg/kg, d1 oxaliplatin 130mg/m2, d1, capecitabine 1000mg/m2, orally, bid (half an hour after breakfast and dinner), d1-14, every 3 weeks, up to 8 cycles. Then patients will be given capecitabine and bevacizumab maintenance treatment. Patients received regular and periodic reviews, with imaging evaluations every 8 weeks. Safety will be evaluated by AE and laboratory tests. All patients were followed up every 3 months until death according to the plan.

NCT ID: NCT03987867 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Study of Autologous CIK Cell Immunotherapy Combination With PD-1 Inhibitor and Chemotherapy in the Advanced NSCLC

Start date: June 1, 2019
Phase: Phase 1
Study type: Interventional

This prospective, unicentric, open-labe phase I study is to evaluate the effects of autologous cytokine-induced killer cell immunotherapy combination with PD-1 inhibitor and chemotherapy in the first-line treatment of IIIB/IIIC/IV non-small cell lung cancer.