Atezolizumab

Chronic Hepatitis B virus (HBV) infection poses a significant public health challenge, particularly in China. Current treatments with interferon or nucleos(t)ide analogues (NAs) achieve sustained Hepatitis B surface antigen (HBsAg) loss—a functional cure—in less than 10% of patients. This study aims to explore a novel combination therapy that includes an immune checkpoint inhibitor (anti-PD-1 antibody) alongside NAs to improve the rate of HBsAg loss, targeting over 50% functional cure in treated patients. The research builds on previous findings and intends to restore immune control by reversing T cell exhaustion caused by HBV infection. Participants will receive either a combination of NAs plus anti-PD-1 antibody or NAs alone. The anti-PD-1 antibody is administered subcutaneously or intravenously once every one to three weeks at a dose lower than that used for cancer treatment, while NAs are taken orally once daily. The study is a phase 2, non-randomized clinical trial conducted across multiple centers and expects to compare safety and efficacy outcomes between these groups to assess the potential of immune checkpoint blockade in achieving higher rates of clinical cure. Throughout the study, participants will have their serum HBsAg, HBV DNA, and alanine aminotransferase (ALT) levels measured at baseline, 24 weeks, 48 weeks after treatment, and 24 weeks post-treatment to monitor response and safety. The study involves regular assessments over a treatment period followed by a post-treatment observation period. Participants will be monitored closely for adverse effects and treatment adherence, contributing to a comprehensive evaluation of this combination strategy's impact on chronic HBV infection.

Chronic Hepatitis B virus (HBV) infection is a significant public health issue in China. Current treatments with interferon alpha (IFNb1) or nucleos(t)ide analogues (NAs) achieve sustained loss of Hepatitis B surface antigen (HBsAg) in less than 10% of patients. Previous research increased this rate to 15% overall and up to 30-50% in patients with lower HBsAg levels using a sequential combination therapy. This trial aims to further improve this functional cure rate by combining immune checkpoint inhibitors targeting the PD-1/PD-L1 pathway with IFNb1 to restore T cell function and enhance immune control against HBV. Participants will receive one of two treatment combinations: NAs plus anti-PD-1 antibody with Peg-IFNb1, or NAs plus Peg-IFNb1 alone. The anti-PD-1 antibody is administered subcutaneously or intravenously at intervals of one to three weeks at doses lower than those used for cancer. NAs are taken orally once daily, and Peg-IFNb1 is given as a weekly subcutaneous injection. This large multicenter prospective study will evaluate safety, efficacy, and rates of HBsAg loss compared to previous studies. During the study, participants will undergo regular assessments including blood tests for HBsAg, HBV DNA levels, and liver enzyme alanine aminotransferase (ALT) at baseline, 24 weeks, 48 weeks, and 24 weeks after treatment ends. Researchers will monitor immune response and safety throughout the trial. The study duration and follow-up will allow evaluation of long-term effects and the potential for a clinical cure to reduce the burden of HBV infection toward global elimination goals by 2030.

Researchers are evaluating a blood-based test called Episwitch CiRT4 to see if it can predict how patients with stage III or IV cancer will respond to immune checkpoint inhibitor (ICI) treatments, specifically PD-(L)-1 inhibitors. This observational study aims to compare test predictions with actual patient responses across different types of cancer. The study also explores how social factors might relate to treatment responses and outcomes. Patients who are candidates for or currently receiving ICI therapy will undergo the Episwitch CiRT4 test before starting or during treatment. If the test indicates a high likelihood of response, repeat testing will occur every three months. Participants will be followed for six months to collect data on treatment administered, disease progression, survival, and patient-reported outcomes, along with social determinants of health. Throughout the study, researchers will gather clinical information, including physician questionnaires and patient feedback, to assess outcomes such as disease-free survival and time to recurrence. The study will also analyze health economics related to the test's potential to reduce unnecessary ICI treatments. Monitoring will continue for 24 weeks, with comprehensive data collection to evaluate the correlation between test results, social factors, and patient outcomes.

Researchers are investigating the use of ablation combined with lenvatinib and a PD-1 inhibitor for advanced hepatocellular carcinoma (HCC) with oligometastasis. This study explores a subtype of metastatic HCC where there are limited metastases, aiming to evaluate whether removing these metastases can improve survival. The trial is a multicenter, prospective, phase II study focused on the safety and effectiveness of this combined approach. Participants receive a treatment combining ablation of oligometastases using microwave ablation, radiofrequency ablation, or cryoablation, along with systemic therapy using lenvatinib and PD-1 inhibitors. Ablation targets metastases limited to five sites in no more than two organs, each measuring up to 5 cm. Patients must have already received at least 3 months of lenvatinib and PD-1 inhibitor therapy with controlled intrahepatic tumors before ablation. Throughout the study, participants will be monitored for progression-free survival over 24 months as the primary outcome. Additional assessments include overall survival, objective response rate, and adverse events within 12 to 24 months. Researchers will perform regular evaluations to track treatment response and safety, with the total study duration extending to August 2027.

This research aims to develop a model to predict early treatment response in patients with advanced hepatocellular carcinoma, a type of liver cancer with a poor prognosis compared to other cancers. The study focuses on comparing the combination therapy of atezolizumab and bevacizumab with each drug alone, as there is currently no information on how to evaluate treatment response early for this combination. The goal is to improve understanding of treatment effects in this patient group. Participants in the study are adults aged 18 to 80 years diagnosed with advanced hepatocellular carcinoma who receive atezolizumab and bevacizumab every three weeks as first-line therapy. Before the second treatment cycle, blood tests and imaging are performed around week 5 to assess early response, followed by standard response evaluations between weeks 9 and 12. This observational study tracks patients receiving standard treatment without altering therapy. During the study, researchers monitor progression-free survival and overall survival, with follow-up continuing until June 22, 2025. Participants undergo blood and imaging tests to evaluate treatment response. The study excludes patients with severe contrast allergies or significant other health problems. Participation involves regular clinical visits and tests over the follow-up period, aiming to gather data for the predictive model.

Researchers are evaluating a combination treatment involving blank-microsphere transcatheter arterial embolization and hepatic arterial infusion chemotherapy (bTAE-HAIC) with the drugs oxaliplatin, 5-fluorouracil, and leucovorin, along with Lenvatinib and Camrelizumab for patients who have intermediate to advanced large hepatocellular carcinoma (liver cancer). This prospective, single-arm study aims to assess the safety and effectiveness of this combined approach, as previous studies have shown individual treatments to be effective but not in this combination. The treatment involves a procedure where a microcatheter is inserted into the artery feeding the tumor, and blank microspheres are delivered based on the tumor's blood supply. After this, chemotherapy drugs are infused directly into the hepatic artery every four weeks. Alongside this, patients receive daily oral Lenvatinib and intravenous Camrelizumab every two weeks. The study focuses on this combination therapy without a comparison group. Participants will be monitored over six months to measure the objective response rate to the treatment. Assessments include clinical evaluations and laboratory tests to monitor liver function, blood counts, and other safety markers. Researchers will also track progression-free survival and other outcomes. The study lasts until December 2025, with careful safety monitoring throughout to evaluate the treatment's effects on tumor response and patient health.

Researchers are evaluating the use of neoadjuvant therapy in patients with stage III and IIB, IIC high-risk acral melanoma. This study focuses on combining Camrelizumab with Apatinib and Temozolomide to explore their potential synergistic antitumor effects and to improve the pathological response rate. Previous studies at this site showed promising clinical response and safety for this combination in unresectable acral melanoma, and this trial aims to assess its benefits in resectable cases. Participants will receive two cycles of neoadjuvant therapy combining Camrelizumab, Apatinib, and Temozolomide before undergoing surgery to remove melanoma. After surgery, patients will continue with adjuvant treatment of Camrelizumab every three weeks for one year. This design allows researchers to study both short-term and long-term effects of this treatment approach. Throughout the study, participants will be monitored for pathological response at weeks 8 to 12 as the primary outcome. Secondary outcomes include objective response rate within six months, recurrence-free survival at one and two years, overall survival up to ten years, safety and tolerability of treatments and surgery, and patient-reported quality of life. The trial spans treatment, surgery, and follow-up periods to gather comprehensive data on efficacy and safety.

Triple-negative breast cancer (TNBC) is a subtype of breast cancer that lacks ER, PR, and Her-2 proteins, making up 15%-20% of all breast cancers. TNBC patients do not benefit from endocrine or HER-2-targeted therapies but respond to cytotoxic drug treatments. Despite improvements, TNBC still has the worst prognosis among breast cancer types. This research evaluates camrelizumab combined with a less toxic anthracycline-free TCb regimen to find safer and more effective neoadjuvant therapy for lymph node-positive TNBC patients. The study compares the safety and effectiveness of two chemotherapy regimens given before surgery: one group receives six cycles of TCb (docetaxel and carboplatin) combined with camrelizumab, a PD-1 inhibitor, and the other group receives six cycles of TCb alone. Each cycle lasts 21 days, with docetaxel and carboplatin administered on the first day, and camrelizumab given on the third day for the experimental group. Participants are randomly assigned in a 2:1 ratio to either group. Participants will undergo assessments including pathological complete response rate within 24 weeks, and longer-term measures like event-free survival, disease-free survival, distant disease-free survival, and objective response rate after surgery. Safety is monitored by recording adverse events after each chemotherapy cycle. The study lasts up to 10 years with follow-up to evaluate long-term outcomes, and participants provide informed consent before enrollment.

Researchers are evaluating a combination treatment of RC48 and Tislelizumab for patients with high-risk upper urinary tract urothelial carcinoma who are seeking kidney preservation. This Phase 2 clinical study aims to assess the safety and effectiveness of this therapy in helping preserve kidney function while treating the cancer. The study follows strict clinical trial quality standards and will enroll about 20 participants. The treatment involves intravenous administration of RC48 at a dose of 2.0 mg/kg every three weeks and Tislelizumab at 200 mg every three weeks. Both drugs are given by intravenous drip over one hour, starting on day 1 of the first 21-day cycle. Participants will receive this combined therapy before undergoing nephron-sparing surgery, aiming to protect kidney function while treating the tumor. During the study, participants will be closely monitored for kidney-intact event-free survival up to one year, along with clinical responses before and after surgery, disease-free survival, and rates of adverse events over two years. Kidney function preservation will be tracked for one year. Participants will provide biopsy tissue and biological samples, and undergo imaging and laboratory tests. The study includes follow-up assessments to evaluate treatment outcomes and safety over time, with total participation lasting up to two years.

Researchers are evaluating the addition of PD-1 treatment to chemo-radiotherapy for high-risk patients with nasopharyngeal carcinoma. This study is a multicenter, open-label, randomized clinical trial comparing outcomes between patients receiving combined PD-1 therapy with chemo-radiotherapy and those receiving chemo-radiotherapy alone. The goal is to see if the combined approach can reduce disease progression and improve survival. Participants are randomly assigned to one of two groups. One group receives three cycles of gemcitabine and cisplatin induction chemotherapy followed by concurrent chemo-radiotherapy with camrelizumab given intravenously during radiotherapy and continued for one year after. The other group receives the same chemotherapy and chemo-radiotherapy without camrelizumab. Radiotherapy is delivered using specific dosing schedules across several target volumes. During the study, participants undergo regular assessments including monitoring for disease progression, survival, treatment-related complications, and quality of life using standardized questionnaires. The primary outcome measured is progression-free survival over three years, with secondary outcomes including overall survival, metastasis-free survival, relapse-free survival, and treatment safety. The total study period extends up to three years for follow-up and evaluation.