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Found 6 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the efficacy and safety of a drug called ICP-248 in adults who have relapsed or refractory mantle cell lymphoma, a type of blood cancer. This is a phase 2, single-arm, multi-center, open-label study, focusing on patients whose disease has returned or not responded to previous treatments including anti-CD20 therapies and BTK inhibitors. Participants in this study will receive ICP-248 orally according to the study protocol. The treatment will be administered as a single-arm intervention, meaning all enrolled patients will receive the same drug without comparison to a placebo or other treatment. There is no additional description of dosing schedules or treatment duration provided. Throughout the study, researchers will monitor the overall response rate (ORR) based on the Lugano 2014 criteria, assessed by an independent review committee over a period of three years. Participants will undergo evaluations to measure tumor response and safety. The study includes follow-up assessments to track long-term outcomes and adverse events during and after the treatment period.
Actively Recruiting
Researchers are studying HS-20093, a fully humanized IgG1 antibody-drug conjugate that targets B7-H3, which is commonly found on solid tumor cells. This phase 2, open-label, multi-center trial evaluates the efficacy, safety, pharmacokinetics, and immunogenicity of HS-20093 as a single treatment in patients with head and neck squamous cell carcinoma (HNSCC) and other advanced solid tumors who have progressed on or are intolerant to standard therapies. The study has two parts: Phase 2a includes two groups — one with patients having recurrent or metastatic HNSCC and another with patients having other advanced solid tumors. Phase 2b focuses only on patients with recurrent or metastatic HNSCC. All participants will receive HS-20093 intravenously at a dose of 10 mg/kg. If the treatment is well tolerated and benefits continue, patients may keep receiving the therapy. Participants will be closely monitored for adverse events during treatment and for 90 days after the final dose. Researchers will assess tumor response using standardized criteria up to 24 months or until disease progression or withdrawal. The study also includes collection of tumor tissue and blood samples, and regular evaluations of patient health and safety throughout the trial.
Actively Recruiting
Researchers are conducting a phase II clinical trial to evaluate the safety, tolerability, and preliminary effectiveness of JS207 in patients with advanced non-small cell lung cancer (NSCLC) who have experienced disease progression after platinum-based chemotherapy and immunotherapy. This study focuses on patients with locally advanced or metastatic NSCLC that cannot be treated with surgery or radical radiochemotherapy. The goal is to understand how JS207 performs in this group who have limited treatment options. Participants receive one of several treatment combinations: JS207 injection alone at 10mg/kg or other dosages; JS207 combined with docetaxel at 75mg/m2 every three weeks; or JS207 combined with JS004 injection at 200mg every three weeks. These treatments are given in cycles spaced three weeks apart, and the study monitors their effects over time. During the trial, researchers will assess the objective response rate over 1.5 years to measure treatment effectiveness. Participants will undergo regular evaluations to monitor safety and tolerability. The study includes adults aged 18 to 75 years, and various assessments will be conducted to track disease status and adverse effects throughout the treatment period.
Actively Recruiting
Researchers are evaluating tamoxifen as an additional therapy for female patients with operable unilateral invasive breast cancer that is estrogen receptor alpha (ER-α) and progesterone receptor (PR) negative but estrogen receptor beta (ER-β) positive. This Phase 3, multicenter, randomized, double-blind study stratifies patients by HER2 status to assess whether tamoxifen improves disease-free survival and overall survival compared to placebo. The study also examines if the level of ER-β expression affects response to hormone therapy. The trial enrolls 688 women aged 18 to 70 years who have undergone neoadjuvant chemotherapy followed by surgery or direct surgery (modified radical mastectomy or breast-conserving surgery). Participants are randomly assigned to receive either tamoxifen 20 mg daily or placebo within six weeks after postoperative chemotherapy and/or radiation therapy, following 2013 NCCN breast cancer guidelines. Patients with HER2-positive tumors may receive targeted therapy (Herceptin) alongside tamoxifen or placebo. Treatment and follow-up continue for eight years. During the study, participants will be monitored for disease recurrence and survival outcomes over ten years from diagnosis. Researchers will assess treatment effects by tracking disease-free survival as the primary outcome. Patients will undergo regular evaluations, including blood tests and cardiac function checks, to ensure safety. The trial aims to provide insights into the benefits of tamoxifen as adjuvant therapy in this specific breast cancer population.
Actively Recruiting
Researchers are evaluating HS-20089, an investigational antibody-drug conjugate that combines a humanized antibody targeting B7-H4 with a chemotherapy agent, in patients with recurrent or metastatic ovarian cancer and endometrial cancer. This phase 2, open-label, multi-center study aims to assess the drug's effectiveness, safety, how it moves through the body, and immune response. The study includes patients with specific types of ovarian, fallopian tube, primary peritoneal, and endometrial cancers who have progressed after prior treatments or are intolerant to standard therapies. The study has two parts: phase 2a and phase 2b. Phase 2a includes four patient groups based on cancer type and treatment history, with dosing of HS-20089 at either 4.8 mg/kg or 5.8 mg/kg given intravenously every three weeks. Phase 2b has two groups focusing on platinum-resistant ovarian cancers and recurrent or metastatic endometrial cancer, where all patients receive the recommended dose determined from earlier data. Treatment continues until disease progression or other reasons for stopping treatment per the study protocol. Participants will be monitored regularly for response to treatment using specific tumor evaluation criteria over up to 24 months or until disease progression or withdrawal. Various assessments include imaging of tumors, safety evaluations, and laboratory tests. Researchers will measure the objective response rate to assess how well the cancer responds to HS-20089. The study also involves collecting tumor tissue samples and monitoring patients for adverse effects, with follow-up continuing as needed during treatment.
Actively Recruiting
Researchers are comparing two types of surgery, Laparoscopic Ileocecal-Sparing Right Hemicolectomy (LISH) and traditional laparoscopic right hemicolectomy (TRH), to treat patients with hepatic flexure colon cancer and proximal transverse colon cancer. This is a prospective, multicenter, open-label, randomized controlled clinical trial. The main goal is to evaluate 3-year disease-free survival after surgery, with additional outcomes including 30-day perioperative complications, pathological findings, colonoscopy results, quality of life, and 5-year overall survival. Patients will be randomly assigned to either the LISH or TRH group in equal numbers. LISH involves preserving the ileocolic blood vessels and performing lymph node dissection along specific vessels, followed by an ileocecal-transverse colonic anastomosis. TRH includes transecting the ileocolic vessels and clearing additional lymph node groups, with ileum-to-transverse colon anastomosis. Both surgeries involve removing colon segments near the tumor based on predetermined margins. Participants will undergo surgery and be monitored for survival and complications over several years. Researchers will assess pathological specimens, lymph node involvement, and colonoscopy findings for new polyps and adenomas. Quality of life will be measured using gastrointestinal symptom and general health questionnaires. The study also includes long-term survival tracking up to five years. Participants must provide informed consent and meet specific clinical and diagnostic criteria.