Pembrolizumab

Researchers are evaluating 177Lu-RAD204, a radiolabeled antibody targeting PD-L1, in a Phase 0/1 study involving participants with advanced solid tumors that express PD-L1. The study aims to assess the safety, tolerability, biodistribution, radiation dosimetry, and preliminary anti-tumor effects of this treatment. The main goal is to find the maximum tolerated dose and recommended doses for future studies in participants with cancers such as NSCLC, SCLC, triple-negative breast cancer, melanoma, head and neck cancer, endometrial cancer, and others with specific genetic markers. The study includes a pre-screening period for PD-L1 testing if needed, followed by a screening period lasting up to four weeks. Participants undergo a Phase 0 Imaging Period where a low dose of 177Lu-RAD204 is given to assess imaging quality, safety, and dosimetry over two weeks. This may be followed by a Phase 1 Treatment Period with escalating doses of 177Lu-RAD204 administered in cycles lasting six weeks each. Participants may receive multiple treatment cycles based on clinical benefit and safety evaluations. Dose-limiting toxicity is monitored for six weeks after the first treatment dose, and dosing intervals may be adjusted as agreed by the study team. During the study, participants will have imaging scans, safety evaluations, and laboratory tests to track the distribution and effects of 177Lu-RAD204. Researchers will measure pharmacokinetics, radiation dosimetry, and tumor responses up to 30 weeks. Safety and tolerability are closely monitored throughout. Participants must meet specific health and tumor criteria to join and will be observed for any adverse reactions. The total duration of participation varies depending on treatment response and tolerability.

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.

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 safety and effectiveness of Cadonilimab combined with chemotherapy as a first or second-line treatment for patients with recurrent or metastatic triple-negative breast cancer (TNBC). TNBC has poor prognosis and limited treatment options. This phase II, open-label, non-randomized study aims to enroll 27 patients to better understand how this combination therapy works compared to chemotherapy alone, addressing limitations caused by toxicities in previous antibody combinations targeting CTLA-4 and PD-1 pathways. Participants will receive Cadonilimab at a dose of 10 mg/kg intravenously every three weeks along with chemotherapy, where the specific chemotherapy regimen is chosen by the treating physician. The study follows a Simon two-stage design and is conducted across multiple centers. This treatment period marks the first or second-line therapy for recurrent or metastatic TNBC, depending on prior chemotherapy timing. During the study, researchers will monitor patients for treatment response using objective response rate measures for up to two years. Safety assessments include tracking adverse events from consent signing through 90 days after the last dose. Participants will undergo evaluations of measurable lesions, performance status, and organ function. The total participation duration includes treatment and follow-up to assess both efficacy and safety outcomes.

Researchers are studying a combination treatment of Cadonilimab, bevacizumab, and FOLFOX chemotherapy for adults with advanced, unresectable metastatic colorectal cancer that is microsatellite stable (MSS) and has a RAS mutation. This Phase II, single-arm, open-label, multicenter trial aims to observe the one-year progression-free survival rate and other outcomes like overall response rate, perioperative safety, and long-term survival in this patient population. Participants will receive the combination of Cadonilimab, bevacizumab, and the FOLFOX chemotherapy regimen as their first-line treatment. This study includes only one experimental treatment group and focuses on evaluating the effects and safety of this combined therapy over time. During the trial, participants will be closely monitored with regular assessments to track their disease progression, treatment response, and any side effects. Researchers will measure outcomes such as the one-year progression-free survival rate, overall response rate, adverse event rates, progression-free survival, and overall survival over 24 months. The study will last up to two years, including safety follow-up and long-term observation.

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.