Vaginal Cancer

Researchers are evaluating the use of 3D-printed custom applicators for intracavitary high-dose-rate (HDR) brachytherapy in patients with gynaecological cancers, including endometrial, vaginal, vulva, and recurrent gynaecological cancers. This Phase IIa non-randomised pilot trial aims to assess the feasibility of treating patients using these patient-specific devices, which could offer a more precise and efficient alternative to traditional cylinder-type applicators or custom wax moulds. The study is sponsored by Royal North Shore Hospital and addresses current challenges in applicator design and construction. Participants will receive treatment using 3D-printed custom applicators designed to match optimal planning specifications for HDR brachytherapy. This innovative approach may reduce the time and labor involved in applicator preparation compared to standard wax moulds, while providing a robust and tailored device for therapy. The study focuses on intracavitary brachytherapy procedures for eligible female patients with certain stages of gynaecological cancer. During the study, patients will be closely monitored for treatment success, radiation therapy toxicities, and quality of treatment plans. Researchers will also evaluate the feasibility of MR-only and CT-only planning procedures, optimize applicator design, and assess resource use and costs. Patient experience and acceptability will be measured via questionnaires over a five-year follow-up. Safety and effectiveness outcomes will be carefully tracked to understand the potential benefits and challenges of this new technology.

Researchers are investigating the use of 3D ultrasound imaging during brachytherapy treatment for gynecological cancers, including primary or recurrent vaginal, endometrial, and cervical cancers. This study aims to improve needle placement accuracy in interstitial or intra-cavitary brachytherapy, which is important for delivering adequate radiation doses to tumors while protecting healthy pelvic organs. Currently, there is no standard real-time image guidance for needle insertion in these procedures, which this research seeks to address. The study involves patients receiving gynecological brachytherapy using a device-based approach, where needles and applicators are inserted under general anesthesia with guidance from clinical exams and pre-procedure MRI. An investigational 3D ultrasound device will be used during the procedure to provide real-time volumetric imaging of needle pathways, improving upon the limitations of standard 2D ultrasound. After the procedure, CT scans are performed for radiation planning. Participants will undergo imaging assessments including MRI before treatment and CT after treatment, with the main focus on measuring the accuracy of needle placement over a 16-month period. The study team will evaluate how effectively the 3D ultrasound helps avoid needle insertion into pelvic organs and optimizes tumor dose coverage. Patient safety and treatment monitoring will be conducted alongside these measurements within the study timeline.

Researchers are evaluating the safety and effectiveness of CD70-targeted CAR-T cells in treating patients with CD70-positive advanced or metastatic gynecologic cancers. This Phase 1 study focuses on patients who have not responded to standard treatments and aims to find the best doses and infusion methods for these CAR-T cell therapies. The study has two groups based on how the CAR-T cells are given: one group receives the treatment through intravenous infusion, and the other through intraperitoneal injection. Each group undergoes two phases: a dose discovery phase that uses a dose-escalating design to find recommended doses, followed by a dose expansion phase to further evaluate safety and effectiveness at those doses. Participants receive doses ranging from 1 to 10 million cells per kilogram. Participants will be closely monitored for adverse events and treatment effects over time. Researchers will assess safety outcomes within the first 28 days after infusion and effectiveness outcomes such as disease control and response rates over three months, with longer-term follow-up up to two years. Various lab tests, imaging scans, and clinical evaluations will be done to track how the CAR-T cells behave and impact the cancer. The total study duration and detailed monitoring are designed to ensure participant safety and collect data on how well the CAR-T cells work.

Researchers are evaluating the safety and effectiveness of a modified herpes simplex virus called recombinant oncolytic herpes simplex virus type 1 (R130) in patients with advanced solid tumors. This early phase 1, open, single-arm clinical trial aims to study the treatment in people with various cancers such as sarcoma, carcinoma, digestive cancer, breast cancer, lung cancer, brain cancer, melanoma, gynecologic cancer, head and neck cancer, and kidney cancer. The study focuses on patients who have not responded to standard treatments or who choose not to receive other antitumor therapies. Participants will receive injections of 1 to 2 milliliters of R130 at a concentration of 1x10^8 plaque-forming units per milliliter into their tumors or abdominal cavity every 7 to 14 days. This approach allows the virus to be delivered directly to the cancer site. The study involves only one treatment group receiving the R130 virus, and no placebo or comparison group is used. During the trial, researchers will monitor participants for adverse events and laboratory abnormalities up to 6 months and assess their immune response. Disease control and response duration will be evaluated every 10 weeks for up to 12 months, while quality of life assessments will occur every 6 weeks for the same period. Participants will undergo regular laboratory tests and clinical evaluations to track safety and treatment impact. The total study duration for each participant may extend up to one year with ongoing monitoring.

Researchers are evaluating TQB2102, an antibody-drug conjugate designed to target Human Epidermal Growth Factor Receptor 2 (HER2) positive tumor cells, in patients with recurrent or metastatic advanced gynecological tumors. This Phase 2 study aims to assess the safety and effectiveness of TQB2102 in this patient population, addressing the need for new treatments after unsuccessful platinum-based chemotherapy. Participants will receive TQB2102 through intravenous infusion every three weeks, with each treatment cycle lasting 21 days. This investigational drug combines a humanized antibody with a potent drug payload to specifically attack tumor cells. The study includes monitoring for adverse events and anti-drug antibodies during treatment and follow-up. During the trial, participants will undergo regular assessments including tumor measurements to evaluate overall response rate, duration of remission, progression-free survival, overall survival, and disease control rate for up to 12 to 17 months. Safety evaluations will continue until 28 days after the last dose or the start of new cancer therapies. Blood samples for anti-drug antibody testing will be collected at specific treatment cycles and after treatment completion. The total involvement period depends on individual treatment duration and follow-up schedules.

Researchers are evaluating the effectiveness and safety of cardunolizumab combined with or without chemotherapy and bevacizumab in treating recurrent or metastatic vulvar and vaginal cancers that cannot be cured with radical treatment. This phase II, single-arm, multicenter prospective study aims to see how this treatment works in women with these cancers. Participants who have not received systematic treatment will receive cardunolizumab with platinum-based doublet chemotherapy, with or without bevacizumab, every three weeks for six cycles followed by maintenance treatment with cardunolizumab with or without bevacizumab every three weeks. Those previously treated with systemic therapy will receive cardunolizumab with chemotherapy chosen by the investigator and with or without bevacizumab following the same schedule. During the study, participants will undergo assessments to measure tumor response using RECIST 1.1 criteria and will be monitored for progression-free survival, overall survival, disease control rate, and duration of response up to 2 years. Adverse events will be tracked from the first dose until 90 days after the last dose. Women must provide tumor tissue samples before enrollment and will be followed for safety and treatment effects over the course of the trial, which starts in March 2024 and ends in March 2027.

Researchers are evaluating the protective effects, safety, and immune response of an 11-valent recombinant human papillomavirus (HPV) vaccine in Chinese women aged 18 to 45 years. This Phase III clinical trial involves 13,500 women divided into three age groups to assess the vaccine's ability to prevent HPV infections and related cervical lesions. Participants are randomized into experimental and placebo groups to compare outcomes. The trial administers three doses of either the HPV vaccine or a placebo via intramuscular injections into the upper arm deltoid muscle, scheduled at 0, 2, and 6 months. The study uses a double-blind design to ensure unbiased results. The vaccine targets multiple HPV types associated with cervical cancer and related conditions. Participants will undergo follow-up visits including gynecological examinations, pregnancy testing, and monitoring for adverse events. Researchers will measure the incidence of cervical intraepithelial neoplasia (CIN) and HPV-related lesions, as well as antibody responses at multiple time points after vaccination. The trial includes long-term monitoring up to six years to evaluate vaccine safety and effectiveness.

Researchers are evaluating the effects of an 8-week Healthy Eating Active Lifestyle (HEAL)-GYN program designed for patients with gynecologic cancer. This telemedicine-based rehabilitation focuses on lifestyle changes including exercise, nutrition, sleep, social integration, stress management, and avoiding risk behaviors like smoking and alcohol. The study aims to assess impacts on participants' confidence in managing their health, lifestyle habits, mental health, overall well-being, and biological markers. The HEAL-GYN program is led by a certified lifestyle medicine oncologist and involves personalized goal-setting and practical instruction on healthy living. Up to 64 participants will engage in this behavioral intervention conducted remotely. The program includes regular monitoring through surveys and wearable activity trackers to measure physical activity and sleep. Participants will complete surveys at the start, end of the 8-week program, and at 1-month and 3-month follow-ups. These surveys use validated tools to assess lifestyle factors, mental health, and quality of life. Home health visits will collect biometric data and blood samples to analyze lab values and biomarkers such as adiponectin, insulin sensitivity, and inflammatory markers. This comprehensive monitoring supports evaluation of the program’s effects over time.

Researchers are evaluating the Integrative Medicine at Home (IM@Home) program to see if it improves patient-reported values, outcomes, and experiences for people undergoing systemic cancer treatments such as chemotherapy, immunotherapy, radiotherapy, targeted agents, or cytoreductive surgery. This program is part of the IMPROVE research initiative and focuses on patients with various cancers including head and neck, thoracic, gynecologic, melanoma, breast, and ovarian cancers. The goal is to assess how virtual mind-body therapies may support cancer patients during their treatment journey. Participants will be randomly assigned to either the IM@Home group or an enhanced usual care group. Those in the IM@Home group will take part in a 12-week virtual program offering weekly synchronous mind-body and fitness classes via Zoom, led by trained therapists with oncology expertise. Classes include activities such as fitness, yoga, dance therapy, tai chi, meditation, guided meditation, and music therapy. Each session lasts 30 to 45 minutes, with time for feedback and discussion. The enhanced usual care group will receive standard care plus access to pre-recorded meditation and relaxation resources. During the 12 weeks, participants will be monitored through patient-reported assessments measuring fatigue severity, symptom intensity, insomnia, psychological distress, pain, treatment expectancy, satisfaction, and session attendance. Researchers will also track treatment disruptions and unplanned medical visits. These evaluations will help determine the impact of the IM@Home program on patient well-being and treatment experience throughout the study period.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of BL-B01D1, an intravenous drug, in patients with multiple solid tumors, including recurrent or metastatic gynecological cancers. This phase Ib/II clinical study aims to find the recommended dose for further trials and assess the drug's initial effects and immune response in these patients. Participants receive BL-B01D1 by intravenous infusion during the first 3-week treatment cycle. Patients who show clinical benefit may continue receiving additional cycles until disease progression, intolerable side effects, or other reasons for stopping treatment occur. The study includes two phases: Phase Ib focuses on safety and dose finding, while Phase II explores efficacy at the recommended dose. During the study, researchers will monitor participants for treatment effects, side effects, and how the drug behaves in the body. They will collect tumor tissue samples, measure tumor response, and assess survival indicators for up to about 24 months. Safety monitoring includes evaluating adverse events and immune reactions. Participants will be followed regularly to assess treatment outcomes and overall health throughout the study period.