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NCT ID: NCT04636047 Recruiting - Lung Cancer Clinical Trials

NGS-based Comprehensive Genomic ctDNA Panel in NSCLC With Immunotherapy

Start date: November 2020
Phase:
Study type: Observational

Liquid biopsy based on next-generation sequencing (NGS) method has become an increasingly powerful detection tool for clinical research and practice. As a companion diagnostic panel, circulating tumor DNA (ctDNA) assay has the considerable potential to detect the blood tumor mutation burden (bTMB), and bTMB calculated by ctDNA assay is regarded as a novel and promising biomarker for immunotherapy nowadays. Though immune checkpoint inhibitors (ICIs) in immunotherapy are highly effective but can induce severe immune-related adverse events (irAEs), which cannot be better predicted in advance. Meanwhile adoptive transfer of T cells transgenic for tumor-reactive T-cell receptors (TCR) is an attractive immunotherapeutic approach. However, clinical translation is so far limited due to challenges in the identification of suitable target antigens as well as TCRs that are concurrent safe and efficient. Definition of key characteristics relevant for effective and specific tumor rejection is essential to improve current TCR-based immunotherapy. This research is to characterize in-depth TCRs derived from HLA-mismatched allogeneic repertoire targeting different myeloperoxidase (MPO)-derived peptides presented by the same HLA-restriction element. Overall the purpose of this trial is to investigate the combined predictive biomarkers (including bTMB and HLA) related to the immunotherapy effects and the biomarker (TCR) associated with adverse reactions during immunotherapy and hold a predictive role, thus further benefit patients receiving immunotherapy, especially in the advanced stage lung cancer patients where tissue samples are unavailable.

NCT ID: NCT04636008 Recruiting - Rectal Cancer Clinical Trials

Sintilimab Plus Hypofractionated Radiotherapy for MSI-H/dMMR Rectal Cancer

Start date: August 14, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This prospective, single-arm study is conducted to investigate the safety and efficacy of Sintilimab combined with hypofractionated radiotherapy in patients with microsatellite instability-high (MSI-H)/ DNA mismatch repair-deficient (dMMR) non-metastatic rectal cancer.

NCT ID: NCT04635956 Recruiting - Chemotherapy Clinical Trials

Camrelizumab Combined With Chemotherapy for Recurrent or Advanced Cervical Neuroendocrine Carcinomas

Start date: November 15, 2020
Phase: Phase 2
Study type: Interventional

Recurrent or advanced cervical neuroendocrine carcinoma (NEC) is refractory to multimodal treatment, even to extensive therapy. Chemotherapy, consisting of platinum and etoposide, remains the main therapy for recurrent or advanced cervical NEC. In addition, bevacizumab has shown progression-free benefits in recurrent or advanced cervical cancer. Case report suggested anti-PD-1 antibody may have antitumor activities in NEC. Based on these evidences, a phase 2, single arm trial is conducted to explore the objective response rate (ORR) of platinum/etoposide/bevacizumab/anti-PD-1 antibody (camrelizumab) for the treatment of recurrent or advanced cervical NEC. This trial is to enroll 20 patients, who would accept 6 courses of platinum/etoposide/bevacizumab/camrelizumab. If the patient achieved complete or partial remission, a total period of 12 months bevacizumab/camrelizumab will be given as maintain therapy. The primary endpoint is ORR. The second endpoints are severe adverse events according to criteria of Common Terminology Criteria for Adverse Events (CTCAE) and iRECIST Guideline, and critical changes of laboratory testing.

NCT ID: NCT04635488 Recruiting - Rectal Cancer Clinical Trials

Prediction Model for Lateral Lymph Node Metastasis

Start date: January 1, 2020
Phase:
Study type: Observational

Mid to low-lying rectal cancer patient with enlarged lateral lymph node befor treatment and receiving lateral lymph node dissection would be enrolled. Radiomics parameters of lateral lymph nodes would be extracted by expert software. Then a part of the nodes would be used as the training set to build the prediction model, and the another part nodes would be used as the validation set.

NCT ID: NCT04634552 Recruiting - Clinical trials for Hematological Malignancies

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

MonumenTAL-1
Start date: February 1, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

NCT ID: NCT04634058 Recruiting - Clinical trials for Cholangiocarcinoma, Intrahepatic

PD-L1 Antibody Combined With CTLA-4 Antibody for Patients With Advanced Intrahepatic Cholangiocarcinoma Who Progressed After Standard Treatment

Start date: November 1, 2020
Phase: Phase 2
Study type: Interventional

The study aims to evaluate the efficacy and safety of PD-L1 antibody combined with the CTLA-4 antibody in patients with advanced ICC who progressed after standard treatment.

NCT ID: NCT04633356 Recruiting - Cirrhosis Clinical Trials

EUS Guided Portal-systemic Pressure Gradient Measurement

Start date: November 12, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Portal hypertension is characterised by an increased portal pressure gradient (PPG), that is the difference in pressure between the portal vein and the inferior vena cava (IVC). Portal hypertension is a consequence of cirrhosis resulting from chronic hepatitis. Patients with portal hypertension are at risk of developing complications including oesophageal or gastric varices, variceal bleeding, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy and mortality. Albeit its clinical significance, direct measurement of portal venous pressure to document portal hypertension has traditionally been difficult. The portal vein pressure can be measured by transhepatic or transvenous methods but the procedure carries a risk of intra-peritoneal bleeding. Furthermore, the IVC pressure measurement requires further transjugular catheterisation. Hence, the technique is rarely used. Currently, the gold standard in measurement of portal hypertension is via measurement hepatic venous pressure gradient (HVPG). The HVPG has been shown to correlate with risk of clinical decompensation, development of varices, hepatocellular carcinoma, variceal bleeding, spontaneous bacterial peritonitis and mortality. Nevertheless, the technique has a low acceptance rate amongst patients and it may not be available even in tertiary medical centres. Recently, the use of EUS-guided approach for measurement of portal pressure gradient (PPGM) has been shown to be feasible. The technical success rate was 100% and no adverse events were reported. Measurements obtained with the EUS approach was shown to correlate excellently with clinical parameters of portal hypertension including presence of varices, portal hypertensive gastropathy and thrombocytopenia. Furthermore, the procedure could be performed at the same time of screening oesophagogastroduodenoscopy (OGD), that is frequently required for variceal screening in this group of patients. Hence, the aim of the current study is to investigate the feasibility of EUS-PPGM and correlate the risk of developing complications with the PPGM in patients that are suffering from chronic hepatitis.

NCT ID: NCT04633330 Recruiting - Clinical trials for Low Grade Squamous Intraepithelial Lesion

Evaluation of AHCC® for the Clearance of High Risk-HPV Infections in Chinese Female

Start date: October 26, 2020
Phase: N/A
Study type: Interventional

This is a multi-centre, randomised, double blind, placebo-controlled study on female participants with diagnosis of high-risk human papillomavirus (HR-HPV) infection to evaluate the clearance capacity of AHCC®.

NCT ID: NCT04633213 Recruiting - Dry Eye Clinical Trials

A Study Evaluating HBM9036 Efficacy and Safety on Moderate to Severe Dry Eye

Start date: February 24, 2021
Phase: Phase 3
Study type: Interventional

The objective of this study is to compare the safety and efficacy of 0.25% HBM9036 (HL036) Ophthalmic Solution to placebo for the treatment of the Chinese subjects with moderate and severe dry eye.

NCT ID: NCT04632108 Recruiting - Clinical trials for Malignant Solid Tumor

A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Patients With Locally Advanced or Metastatic Solid Tumors

Start date: January 28, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label Phase 1/2 study, the purpose of the trial is to assess the safety, tolerability, pharmacokinetics, and antitumor activity of ASKB589 in patients suffering from advanced or metastatic solid tumors. Patients with gastric cancer/gastroesophageal junction adenocarcinoma and pancreatic cancer are preferred.