Publications by authors named "Yuxian Bai"
Introduction: This study aimed to evaluate the safety and preliminary efficacy of serplulimab, a novel programmed death-1 inhibitor, with or without bevacizumab biosimilar HLX04 as first-line treatment in patients with advanced hepatocellular carcinoma.
Methods: This open-label, multicenter phase 2 study (clinicaltrials.gov identifier NCT03973112) was conducted in China and consisted of four treatment groups: group A (serplulimab 3 mg/kg plus HLX04 5 mg/kg, subsequent-line), group B (serplulimab 3 mg/kg plus HLX04 10 mg/kg, subsequent-line), group C (serplulimab 3 mg/kg, subsequent-line) and group D (serplulimab 3 mg/kg plus HLX04 10 mg/kg, first-line).
This phase 2/3 trial (NCT04856787) assessed the efficacy and safety of SHR-1701, a bifunctional protein targeting PD-L1 and TGF-β, in combination with BP102 (a bevacizumab biosimilar) and XELOX (capecitabine plus oxaliplatin) as a first-line treatment for unresectable metastatic colorectal cancer (mCRC). In this phase 2 study, a total of 62 patients with untreated, histologically confirmed colorectal adenocarcinoma and no prior systemic therapy for metastatic disease were enrolled. Patients received SHR-1701 (30 mg/kg), bevacizumab (7.
View Article and Find Full Text PDFArticle Synopsis
- Liposomal irinotecan (HR070803) combined with 5-fluorouracil and leucovorin shows enhanced overall survival in patients with advanced pancreatic cancer previously treated with gemcitabine-based therapies, as demonstrated in a phase 3 study.
- The trial involved 298 patients, showing a median overall survival of 7.4 months for the HR070803 group compared to 5.0 months for the placebo group, with statistically significant results.
- While there were some adverse events, such as increased liver enzyme levels and decreased white blood cell counts, the safety profile was manageable, with no treatment-related deaths in the HR070803 group, highlighting its potential as a second-line treatment option for this patient
Article Synopsis
- Sitravatinib is a targeted treatment for advanced cancers, specifically focusing on TAM receptors and others, and was tested in a study (SAFFRON-104) for its effectiveness alone or with another drug (tislelizumab) in advanced liver or stomach cancers.
- The study included 111 patients, and the recommended dosage of sitravatinib was established at 120 mg daily. Results showed that about 25% of patients experienced a positive response to sitravatinib alone, while those receiving it with tislelizumab had lower response rates.
- Overall, the combination of sitravatinib and tislelizumab was generally safe with manageable side effects, indicating preliminary
Background: The interim analysis of the randomized phase 3 ESCORT-1st study demonstrated significantly longer overall survival (OS) and progression-free survival (PFS) for camrelizumab-chemotherapy than placebo-chemotherapy in untreated advanced/metastatic esophageal squamous cell carcinoma (ESCC). Here, we present the final analysis of this study and investigate potential indicators associated with OS.
Methods: Patients were randomized 1:1 to receive camrelizumab (200 mg) or placebo, both in combination with up to six cycles of paclitaxel (175 mg/m) and cisplatin (75 mg/m).
Article Synopsis
- * Results showed a significant improvement in progression-free survival (PFS) for those receiving fruquintinib (5.6 months) compared to the placebo group (2.7 months), but overall survival (OS) was not significantly different between the two groups (9.6 months vs. 8.4 months).
- * The most common serious side effects of the treatment included neutropenia, leukopenia, and anemia, suggesting that while fruquintinib can extend
Article Synopsis
- The study aimed to assess the effectiveness and safety of tislelizumab combined with chemotherapy for advanced gastric cancer compared to a placebo with chemotherapy.
- Conducted from December 2018 to February 2023 across multiple continents, it involved 1,657 adult patients with specific cancer types who had not previously undergone systemic treatment.
- Results indicated that patients receiving tislelizumab plus chemotherapy experienced significant improvements in overall survival compared to those on placebo and chemotherapy.
Background: Effective systemic therapy remains limited for advanced esophageal squamous cell carcinoma (ESCC) and hepatocellular carcinoma (HCC), particularly after prior failed treatment with immune checkpoint inhibitors (ICIs). Theoretically, a combination of tyrosine kinase inhibitors (TKIs) with ICIs may restore immunotherapy sensitivity.
Methods: In this phase 1b study, patients received AL2846, an antiangiogenic TKI with multiple targets (c-MET, VEGFR1, c-KIT, Axl, RET, KDR, and VEGFR3), in combination with an anti-PD-L1 antibody (TQB2450) until disease progression, intolerable toxicity, death, or discontinuation for any cause.
To evaluate pembrolizumab in patients of Chinese descent with microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) tumors enrolled in KEYNOTE-158 (Cohort L). Patients with MSI-H/dMMR advanced tumors received pembrolizumab 200 mg IV Q3W. Primary end point was overall response rate (ORR).
View Article and Find Full Text PDFAlthough antiprogrammed death 1 antibody plus chemotherapy has recently been approved for first-line esophageal squamous cell carcinoma (ESCC), antiprogrammed death-ligand 1 antibody may offer another combination option in this setting. In this multicenter, randomized, double-blinded phase 3 trial a total of 540 adults (aged 18-75 years) with unresectable, locally advanced, recurrent or metastatic ESCC and who had not received systemic treatment were enrolled. All patients were randomized at 2:1 to receive either sugemalimab (an anti-PD-L1 antibody; 1,200 mg) or placebo every 3 weeks for up to 24 months, plus chemotherapy (cisplatin 80 mg m on day 1 plus 5-fluorouracil 800 mg m day on days 1-4) every 3 weeks for up to six cycles.
View Article and Find Full Text PDFBackground: Limited therapeutic options are available for metastatic colorectal cancer (mCRC) patients after failure of first- and second-line therapies, representing an unmet medical need for novel therapies.
Methods: This is an open-label, single arm, multicenter, phase Ⅱ study aiming to perform the efficacy, safety and genomic analysis of SCT200, a noval fully humanized IgG1 anti-epidermal growth factor receptor (EGFR) monoclonal antibody, in patients with fluorouracil, irinotecan and oxaliplatin refractory RAS and BRAF wild-type mCRC. SCT200 (6 mg/kg) was given weekly for the first six weeks, followed by a higher dose of 8 mg/kg every two weeks until disease progression or unacceptable toxicity.
Importance: Gastric and gastroesophageal junction cancers are diagnosed in more than 1 million people worldwide annually, and few effective treatments are available. Sintilimab, a recombinant human IgG4 monoclonal antibody that binds to programmed cell death 1 (PD-1), in combination with chemotherapy, has demonstrated promising efficacy.
Objective: To compare overall survival of patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancers who were treated with sintilimab with chemotherapy vs placebo with chemotherapy.
We report a multicenter, phase 2 study evaluating the efficacy of pucotenlimab, an anti-PD-1 antibody, in patients with mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumors, and potential biomarkers for response. Overall, 100 patients with previously treated, advanced solid tumors centrally confirmed as dMMR or MSI-H received pucotenlimab at 200 mg every 3 weeks. The most common cancer type is colorectal cancer (n = 71).
View Article and Find Full Text PDFObjective: Currently, pre-treatment prediction of patients with pancreatic neuroendocrine tumors with liver metastases (PNELM) receiving surufatinib treatment was unsatisfying. Our objective was to examine the association between radiological characteristics and efficacy/prognosis.
Methods: We enrolled patients with liver metastases in the phase III, SANET-p trial (NCT02589821) and obtained contrast-enhanced computed tomography (CECT) images.
Purpose: This multicenter, open-label, phase Ib/II study aimed to assess the efficacy and safety of cadonilimab, a humanized, tetravalent, bispecific antibody plus lenvatinib in first-line treatment of advanced hepatocellular carcinoma (aHCC).
Methods: Patients with histologically confirmed aHCC were included to receive either 6 mg/kg cadonilimab every 2 weeks plus lenvatinib (cohort A) or 15 mg/kg cadonilimab every 3 weeks plus lenvatinib (cohort B). The primary endpoint was objective response rate (ORR) by RECIST v1.
Article Synopsis
- The study looked at how well a treatment called pembrolizumab works when combined with chemotherapy for patients with a specific type of stomach cancer.
- It was a big trial done in hospitals around the world with patients who hadn't received treatment before and had a certain type of cancer.
- Researchers wanted to see if the combination of pembrolizumab and chemotherapy helped patients live longer compared to those who just got placebo (a fake treatment) with chemotherapy.
Background: Evidence for the efficacy of combined PD-1 and HER2 blockade with chemotherapy on progression-free and overall survival in HER2-positive gastro-oesophageal cancer is scarce. The first interim analysis of the randomised, phase 3 KEYNOTE-811 study showed a superior objective response with pembrolizumab compared with placebo when added to trastuzumab plus fluoropyrimidine and platinum-based chemotherapy. Here, we report results from protocol-specified subsequent interim analyses of KEYNOTE-811.
View Article and Find Full Text PDFArticle Synopsis
- Hepatocellular carcinoma (HCC) is a major cause of cancer deaths, and there is a need for new first-line treatment options; tislelizumab, a PD-1 inhibitor, shows promise as a second-line treatment.
- The RATIONALE-301 clinical trial compares the efficacy and safety of tislelizumab and sorafenib in treating unresectable HCC in newly diagnosed patients.
- Results indicate that tislelizumab meets the criteria for noninferiority in overall survival compared to sorafenib, with a median overall survival of 15.9 months vs. 14.1 months; however, it did not demonstrate superiority, while showing a higher objective response rate (14.3%
Purpose: In a phase IIb trial of nimotuzumab plus gemcitabine, substantial clinical benefits were observed in patients with locally advanced or metastatic pancreatic cancer (PC). Therefore, we conducted a phase III clinical study to verify the efficacy and safety of this combination regimen in patients with K-Ras wild-type tumors (ClinicalTrials.gov identifier: NCT02395016).
View Article and Find Full Text PDFBackground: Immunotherapy with immune checkpoint inhibitors combined with an anti-angiogenic tyrosine-kinase inhibitor (TKI) has been shown to improve overall survival versus anti-angiogenic therapy alone in advanced solid tumours, but not in hepatocellular carcinoma. Therefore, a clinical study was conducted to compare the efficacy and safety of the anti-PD-1 antibody camrelizumab plus the VEGFR2-targeted TKI rivoceranib (also known as apatinib) versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma.
Methods: This randomised, open-label, international phase 3 trial (CARES-310) was done at 95 study sites across 13 countries and regions worldwide.
Introduction: Current treatments for patients with previously treated advanced hepatocellular carcinoma (HCC) provide modest survival benefits. We evaluated the safety and antitumor activity of serplulimab, an anti-PD-1 antibody, plus the bevacizumab biosimilar HLX04 in this patient population.
Methods: In this open-label, multicenter, phase 2 study in China, patients with advanced HCC who failed prior systemic therapy received serplulimab 3 mg/kg plus HLX04 5 mg/kg (group A) or 10 mg/kg (group B) intravenously every 2 weeks.
Objective: Apatinib and irinotecan are used as systematic therapies for advanced gastric adenocarcinoma (GAC) and gastroesophageal junction adenocarcinoma (GEJA), while the evidence for their combination as second-line therapy in these patients is limited. This study aimed to evaluate the efficacy and safety of second-line apatinib plus irinotecan for the treatment of GAC and GEJA.
Methods: In this prospective, multicenter phase II clinical study, 28 patients with advanced GAC or GEJA who received second-line apatinib plus irinotecan were recruited.
Background: Apatinib, a highly selective VEGFR2 inhibitor, significantly improved efficacy versus placebo as a third- and later-line treatment for advanced gastric cancer in phase 2 and 3 trials. This prospective, single-arm, multicenter phase IV AHEAD study was conducted to verify the safety and efficacy of apatinib in patients with advanced or metastatic gastric or gastroesophageal adenocarcinoma after at least two lines of systematic therapy in clinical practice settings.
Methods: Patients with advanced gastric cancer who had previously failed at least two lines of chemotherapy received oral apatinib until disease progression, death or unacceptable toxicity.
Background: Although immunotherapy combined with targeted therapy can be effective for hepatocellular carcinoma (HCC), not all HCC patients respond to this treatment. Models for predicting tumour response in HCC patients receiving immunotherapy combined with targeted therapy are lacking.
Methods: A total of 221 HCC patients from two independent prospective cohorts were retrospectively reviewed.