A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum...
Ovarian NeoplasmsEndometrial Neoplasms4 moreMulticenter, randomized, open-label, phase II clinical study comparing Dostarlimab +/- Bevacizumab with standard chemotherapy in patients with gynecological clear cell carcinoma. 198 subjects will be enrolled in this study and will be assigned to three groups in a 1:1:1 ratio. Group A: Dostarlimab monotherapy First 3 cycles: Dostalimab 500mg every 3 weeks, IV 4 cycles ~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV Group B: Dostarlimab + Bevacizumab combination therapy First 3 cycles: Dostalimab 500mg every 3 weeks, IV 4 cycles ~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV Bevacizumab administered IV at 15 mg/kg every 3 weeks until disease progression or unacceptable toxicity Group C: General chemotherapy (one of doxorubicin, paclitaxel, and gemcitabine)
Efficacy of Chemotherapy Alone in Patients With Poor-differentiated Early-stage Cervical Cancer...
Cervical CancerThis study is aimed to enroll patients with early-stage cervical cancer (FIGO 2018 IB1-IB2) who undergo radical hysterectomy and the postoperative pathology doesn't meet Sedlis criteria or the "four-factor" model but with poorly differentiated squamous/adenocarcinoma/adenosquamous carcinoma. Patients will be randomly divided into two groups in a 1:1 ratio. The experimental group received 4 courses of paclitaxel and cisplatin (once every 3 weeks) for adjuvant chemotherapy within 4 weeks after surgery, while the control group don't not receive any adjuvant therapy but only received regular follow-up. The disease status of all patients will be evaluated within 4 weeks after the end of all treatment and every 12 weeks thereafter, including gynecological examination, laboratory indicators, imaging evaluation, and the prognosis of the two groups will be compared.
A Phase II Study of Serplulimab Plus Bevacizumab in Combination With Chemotherapy in 1L Treatment...
Cervical CancerThis study is a single-arm, multicenter, Phase II study to evaluate the efficacy and safety of the treatment of Serplulimab plus Bevacizumab in combination with chemotherapy in 1L treatment of patients with untreated recurrent or metastatic cervical cancer. Approximately 48 eligible subjects are planned to be enrolled across all sites. The dosing regimen is: Serplulimab plus Bevacizumab combined with chemotherapy (cisplatin, paclitaxel). Each cycle is 21 days (every 3 weeks). Subjects will receive Cisplatin plus Paclitaxel up to 4-6 cycles. The maximum duration of treatment with Serplulimab is 2 years (up to 35 cycles). During the study treatment period, the subjects will receive imaging examination and response assessments every 6 weeks (± 7 days) in the first 48 weeks, every 9 weeks (± 7 days) in 48-96 weeks, and then every 12 weeks (± 7 days). After the treatment discontinuation visit, the subjects will enter the safety follow-up period and survival follow-up period.
Estimation of Tumor Response With Linac MRI-guided Adaptive Radiotherapy for Locally Advanced Cervical...
Locally Advanced CancerThe management of locally advanced cervical cancer (Figo >IB) is based on radiochemotherapy (RCT) followed by brachytherapy. At present there is no personalized treatment, all patients undergoing radiochemotherapy will follow a conventional treatment by external radiotherapy (46 Gy in 23 sessions associated with cisplatin (CDDP) weekly) and brachytherapy to achieve a total equivalent biological dose around 80-90 Gy).The efficacy of this treatment has been proven for most patients, almost 80% being in complete response after RCT. Nevertheless, on an individual scale, there remains a significant variation in the tumor response, with patients who respond from the first week of treatment, "early responders" or, on the contrary, others who present significant tumor residues after external beam radiotherapy.Various macroscopic tumor volume (GTV) response patterns have been identified based on magnetic resonance imaging (MRI) at diagnosis and MRI before brachytherapy, implying very different clinical target volumes for brachytherapy technique. The difference in tumor volume response has been identified as having a major impact on treatment response. This is the first study attempting to evaluate tumor response in real time during radiochemotherapy treatment. Knowing the tumor response during treatment will make it possible to modify the management of locally advanced cervical cancer, several therapeutic options might then be discussed depending on the early response to treatment: dose de-escalation for early responders, reduction of time total treatment, personalization of brachytherapy management (technique and dose). This observational study will allow rapid identification of responder and non-responder patients and might be used as a basis for personalized treatment strategies
Randomized Implementation of Primary HPV Testing in the Organized Screening for Cervical Cancer...
High-grade Cervical Intraepithelial NeoplasiaThe purpose is to evaluate whether implementation of primary human papillomavirus (HPV) screening in the screening programme for cervical cancer improves the programme in terms of better cancer protection and better cost efficiency.
Model Development and Prospective Validation to Predict the Response to Neoadjuvant Chemotherapy...
Cervical CancerCervical cancer is one of the major health problems for chinese women. Besides surgery and radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many studies. However, not all patients respond well to neoadjuvant chemotherapy. Knowing the therapeutic effect of the neoadjuvant chemotherapy before receiving it can not only reduce the economic burden, but also more importantly save time to take more suitable treatments. This study is undertaken to build a model combine both clinical and genetic factors to predict the effects of neoadjuvant chemotherapy.
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers...
HPV-Associated Cervical CarcinomaHPV-Related Carcinoma15 moreThe goal of this study is to determine the feasibility of administration of a single dose of E7 TCR-T cells as induction therapy prior to definitive treatment (chemoradiation or surgery) of locoregionally advanced HPV-associated cancers. The intent of E7 TCR-T cell treatment is to shrink or eliminate tumors and thereby facilitate definitive therapy and increase overall survival. This study seeks to determine 1) if E7 TCR-T cell can be administered without undue delay in definitive treatment, 2) the tumor response rate to E7 TCR-T cell treatment, 3) and the disease-free survival rate at 2 and 5 years. Participants will undergo an apheresis procedure to obtain T cells that will be genetically engineered to generate E7 TCR-T cells. They will receive a conditioning regimen, a single infusion of their own E7 TCR-T cells, and adjuvant aldesleukin. Participants will follow up to assess safety and determine tumor response and will return to their primary oncology team for definitive therapy.
Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer
Advanced Cervical CarcinomaCervical Cancer2 moreAdvanced cervical cancer patients treated with standard of care (SOC) chemoradiation plus glutaminase inhibition with telaglenastat (CB-839) will have increased progression-free survival (PFS) compared to historical rates for patients receiving SOC chemoradiation alone.
Anlotinib Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Cervical...
To Evaluate the Efficacy and Safety of Anlotinib Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced Cervical CancerTo observe the efficacy and safety of hydrochloride anlotinib combined with concurrent radiochemotherapy for patients with FIGO stage IB3 and IIA2-IVA cervical cancer.
Telecytology as a Triage Tool in LMICs
Cervical CancerWe will collect PAP-test samples from women undergoing colposcopy. Laboratory providers will prepare the samples with a liquid-based cytology method. The providers will then digitalise the slides using a digital scanner. The slides will be sent to cytopathologists who will assess the quality of the slides.