Cadonilimab/Anlotinib in Locally Advanced or Relapsed/Metastatic ESCC Patients After Failure of...
Esophageal Squamous Cell CarcinomaAdvanced esophageal squamous cell carcinoma patients who have failed first-line PD-1 inhibitor combined with chemotherapy lack a standard treatment option. Second-line treatments have limited efficacy, indicating a significant unmet clinical need. Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) has anti-tumor angiogenesis and tumor growth inhibition effects. Cadonilimab is a human immunoglobulin (Ig) G1 monoclonal antibody (mAb), which is a bispecific antibody that blocks both PD-1 and CTLA-4. Both of them have shown certain efficacy and good safety in more than second-line therapy for patients with advanced esophageal squamous cell carcinoma as monotherapy. This study aims to evaluate the efficacy and safety of cadonilimab combined with anlotinib in patients with locally advanced or recurrent/metastatic esophageal squamous cell carcinoma who have progressed on PD-1 inhibitor combined with platinum-containing chemotherapy.
Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous...
Esophageal Squamous Cell CarcinomaEsophageal cancer is one of the most common malignancies in China, and esophageal squamous cell carcinoma (ESCC) is the predominant histological type. Surgical resection is still a standard therapeutic approach for patients with resectable ESCC, but the prognosis is still disappointing. Although neoadjuvant chemoradiotherapy plus surgery is currently recommended for patients with locally advanced ESCC, it is still an infrequently used procedure in China. The efficacy of adjuvant therapy on ESCC is still controversial. Recently, the CheckMate 577 trial showed that adjuvant nivolumab therapy could improve DFS for patients with residual disease after neoadjuvant chemoradiotherapy plus surgery. However, no optimal postoperative adjuvant therapy was recommended for patients with ESCC received upfront surgery. We designed a prospective randomized controlled tial to study whether immunotherapy could be used with chemotherapy after surgery to improve overall survival in these patients. The primary endpoint of the study is disease free survival, with secondary endpoints of overall survival, safety and toxicity, and quality of life.
The Effect of Prebiotic Inulin on Patients Affected by R/M HNSCC Treated With Immune Checkpoint...
Head and Neck Squamous Cell CarcinomaThe PRINCESS study is a hypothesis-generating, interventional, open-label, non pharmacological trial designed to characterize the translational and clinical implications of the regular assumptions of inulin on Gut Microbiota, circulating cytokines and immune cells dynamics during ICIs +/- chemotherapy on patients affected by R/M HNSCC.
Cetuximab Plus Dalpicilib in Patients With HPV Negative, PD-1 Resistant R/M HNSCC
Recurrent/Metastatic Head and Neck Squamous Cell CarcinomaThis study is the first clinical study in PD-1 resistant patients with head and neck squamous cell carcinoma with drugs targeting EGFR signaling pathway combined with CDK4/6 inhibitors, which explores the new combination therapies urgently needed in clinical practice and lays a foundation for subsequent studies, with important scientific research significance and clinical value.
FLASH Radiotherapy for Skin Cancer
Basal Cell CarcinomaCutaneous Squamous Cell CarcinomaThis is a single center randomized selected Phase II study of FLASH radiotherapy (RT) versus standard of care (SOC) radiotherapy in patients with localized Cutaneous Squamous Cell Carcinoma (cSCC) or Basal Cell Carcinoma (BCC). In summary, the aims of the study are to describe and compare the toxicity and efficacy of high dose rate radiotherapy (FLASH therapy) to SOC conventional radiotherapy (according to the standard guidelines per lesion size) through a randomized Phase II selection study in patients presenting localized cSCC or BCC requiring a radiotherapy treatment.
TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and...
Head and Neck NeoplasmsThe purpose of this trial is to evaluate the safety and efficacy of TransCon TLR7/8 Agonist, TransCon IL-2 β/γ, and pembrolizumab given prior to curative intent surgery in treatment of participants with newly diagnosed Stage III/IVA resectable locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). After surgery, participants will receive local standard-of-care treatment and will be followed for safety, efficacy, and survival for up to 2 years. This trial contains a safety run-in to evaluate the safety and tolerability of the two treatment arms: Arm A (TransCon TLR7/8 Agonist plus pembrolizumab) and Arm B (TransCon TLR7/8 Agonist plus TransCon IL-2 β/γ). The safety run-in will be followed by the randomized Phase 2, open-label part of the trial comparing the safety, efficacy and survival of treatment Arm A or Arm B compared to treatment Arm C (pembrolizumab monotherapy).
Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell CarcinomaEsophageal Cancer1 moreSCR-ESCC-01 is a multicenter, randomized, phase II study aiming to investigate the benefit of early involvement of low-dose radiotherapy(LDRT) and conventionally fractionated radiotherapy(CFRT) in the first-line anti-PD-1 based treatment of metastatic ESCC.
Dose De-escalation and Sentinel LN Mapping Driven Radiotherapy of Contralateral Neck in Ipsilateral...
Squamous Cell Carcinoma of Head and NeckThe study involves head and neck squamous cell carcinomas (HNSCC) of the oral cavity, oropharynx, larynx or hypopharynx with positive nodes on only one side of the neck and no distant metastasis treated by primary (chemo)radiotherapy. The elective node irradiation on the contralateral side is not always mandatory and the dose may be too high. In this study, we evaluate two strategies: the impact of sentinel lymph node mapping to tailor the volumes to irradiate and the dose reduction.
Olaparib in Combination With Pembrolizumab and Carboplatin as First-Line Treatment of Recurrent...
Recurrent Head and Neck Squamous Cell CarcinomaMetastatic Head and Neck Squamous Cell CarcinomaIn this study, patients with recurrent or metastatic head and neck squamous cell carcinoma will receive first line treatment with olaparib, pembrolizumab, and carboplatin. The primary hypothesis is that olaparib, pembrolizumab and carboplatin will result in an overall response rate (ORR) higher than the historical ORR observed with pembrolizumab, platinum and 5-FU.
Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer
Head and Neck Carcinoma of Unknown PrimaryLocally Recurrent Head and Neck Squamous Cell Carcinoma4 moreThis phase I trial is to find out the possible side effects of pembrolizumab and radiation therapy before and during surgery in treating patients with head and neck squamous cell cancer that remains despite treatment (persistent) or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. Giving pembrolizumab and radiation therapy before and during surgery may kill more tumor cells.