scholarly journals Paclitaxel liposome for injection (Lipusu) plus cisplatin versus gemcitabine plus cisplatin in the first‐line treatment of locally advanced or metastatic lung squamous cell carcinoma: A multicenter, randomized, open‐label, parallel controlled clinical study

2021 ◽  
Author(s):  
Jie Zhang ◽  
Yueyin Pan ◽  
Qin Shi ◽  
Guojun Zhang ◽  
Liyan Jiang ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Locally Advanced ◽  
Lung Squamous Cell Carcinoma ◽  
Line Treatment ◽  
First Line ◽  
Open Label ◽  
Metastatic Lung ◽  
Paclitaxel Liposome ◽  
Controlled Clinical Study ◽  
First Line Treatment

Efficacy and safety of SHR-1210 combined with apatinib in first-line treatment for advanced lung squamous cell carcinoma: A phase II study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21587-e21587
Author(s):  
Jinliang Wang ◽  
Zhibo Zhang ◽  
Xiang Yan ◽  
Junxun Ma ◽  
Fan Zhang ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Interstitial Pneumonia ◽  
Phase Ii Study ◽  
Lung Squamous Cell Carcinoma ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
First Line ◽  
First Line Treatment

e21587 Background: PD-1 inhibitors plus chemotherapy is a standard of first-line therapy in advanced lung squamous cell carcinoma (LUSC). Previous preclinical and clinical studies suggested that the combination of anti-PD-1 antibody SHR-1210 and VEGFR-2 inhibitor apatinib significantly improved anti-tumor effects. The aim of this study was to evaluate the efficacy and safety of SHR-1210 in combination with apatinib for advanced LUSC patients as a first-line treatment. Methods: In this phase II study, patients diagnosed with stage IIIB or IV advanced LUSC were enrolled. All patients received SHR-1210 (200mg q2w) and apatinib (250mg po qd) until disease progression or unacceptable toxicity. Treatment efficacy was assessed every 3 cycles (6 weeks). The primary endpoint is progression-free survival (PFS). Secondary endpoints are objective response rate (ORR), disease control rate (DCR), and overall survival (OS), which according to RECIST 1.1. Results: At the primary analysis (data cutoff Feb 10, 2020), 26 advanced LUSC patients had enrolled, and 17 patients of which were evaluable. Baseline characteristics were shown that median age was 67 years, male percentage was 92.3% (24/26), and clinical stage IV percentage was for 57.7% (15/26). The median follow-up time was 3.1 months (range 0.4-13.7 months) in all included patients. No complete response (CR) was reported. Partial response (PR) was achieved in 13 (76.5%) and stable disease (SD) in 4 (23.5%). The ORR and DCR in 17 evaluable patients were 76.5% and 100%, respectively. The most common treatment-related adverse events were hypertension (42.3%), rash (38.5%), hand-foot skin reaction (26.9%), and reactive cutaneous capillary endothelial proliferation (RCCEP) (15.4%). Of 26 patients, 5 experienced a grade ≥3 treatment-related adverse events, including one interstitial pneumonia, one hypertension, one thrombocytopenia, one RCCEP, and one aminotransferase elevation. Three patients (3/26) were reported dead, of which one died due to interstitial pneumonia and the others died of tumor progression. Twelve patients (46.2%) ever suspended treatment or adjusted the dosage of apatinib due to interstitial pneumonia, pyelonephritis, rash, thrombocytopenia, or aminotransferase elevation. Conclusions: The combination of SHR-1210 and apatinib for advanced LUSC patients was well tolerated and effective. This treatment may be a promising method for advanced LUSC as a first-line treatment. Fund Project (No: 2017FC-CXYY-3007) & Project (No: 2017MBD-013). Clinical trial information: ChiCTR1800019329.

Efficacy observation of albumin-bound paclitaxel combined with S1, sequential and alternate gemcitabine combined with oxaliplatin in the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC): A single-arm, prospective study.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 409-409
Author(s):  
Zhiwei Li ◽  
Qingwei Li ◽  
Xiaona Fan ◽  
Dan Wang ◽  
Changjie Lou ◽  
...  
Keyword(s):  
Prospective Study ◽  
Locally Advanced ◽  
Sequential Treatment ◽  
Ductal Adenocarcinoma ◽  
Line Treatment ◽  
First Line ◽  
Open Label ◽  
Exact Test ◽  
Number Of Patients ◽  
First Line Treatment

409 Background:Chemotherapy is effective in mPDAC but the effect is not satisfactory. Alternate sequential treatment appears to be feasible and effective, with manageable toxicities and decreased neurotoxicity. Similar studies have not been carried out in China. Therefore, we evaluated the efficacy and safety of albumin-bound paclitaxel combined with S1, sequential and alternate gemcitabine combined with oxaliplatin in the first-line treatment of patients with mPDAC. Methods:Based on an expected 6-month PFS rate of 45% and a threshold 6-month PFS rate of 25%, a one-sided exact test is applied setting α = 0.025. The number of patients required for a power of 80% was calculated to be 24. Considering the drop rate of 15%, 30 patients need to be enrolled in the experiment. This open-label, single-arm, prospective study enrolled patients with locally advanced and metastatic pancreatic cancer, who have not received prior chemotherapy regimens and radiation therapy between Jan, 2019 and Dec, 2020. The patient receives the NS regimen first:albumin-bound paclitaxel(125mg/m2) was administered for the first and eighth day by intravenous drip and S1 (40-60 mg)was administered orally twice a day for 2 cycles with 3-week cycle. Then the GEMOX regimen is applied sequentially and alternately: Gemcitabine (1000mg/m2, intravenous infusion for 30 minutes, administration on the first and eighth days) and oxaliplatin (130mg/m2, intravenous injection for 2 hours, administration on the second day) were given for 2 cycles with 3-week cycle. After that, the NS and GEMOX regimen were alternately used again. The treatment was continued until disease progression or unacceptable toxic effects. Results:In this study, 36 eligible patients received the sequential treatment of the above regimen with a median age of 59 years (range 35 to 67 years). 24 patients were eligible for efficacy analysis. Median follow up time was 8.8 months. 45.8% (11/24) of patients completed 3 alternating (8 cycles) treatment, and 33.3% (8/24) of patients completed 2 alternating (6 cycles) treatment, other patients only completed 1 alternate treatment. 6-month PFS rate was 70.8%(17/24), The median PFS of 24 patients was 8.9 months. The final OS and PFS was not yet achieved. The most common grade 3/4 treatment related AEs were thrombocytopenia (13.33%), granulopenia (8.3%), peripheral nerve toxicity (5.6%), and all adverse reactions could be recovered to less than grade 2 after suspension of medication or reduction of dose. Conclusions: The treatment of albumin-bound paclitaxel combined with S1, sequential and alternate gemcitabine combined with oxaliplatin showed promising efficacy and manageable toxicities in patients with mPDAC, and required more prospective patients to be enrolled. Clinical trial information: ChiCTR1900024867.

scholarly journals 406 Camrelizumab combined with paclitaxel and nedaplatin in the first-line treatment of locally advanced/advanced esophageal squamous cell carcinoma: a phase II, single-arm, exploratory research

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A437-A437
Author(s):  
Jianqun Ma ◽  
Jinfeng Zhang ◽  
Yingnan Yang ◽  
Dayong Zheng ◽  
Xiaoyuan Wang ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Esophageal Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Ethics Committee ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

BackgroundTreatment options for patients with locally advanced/advanced esophageal squamous cell carcinoma (ESCC) are limited. Current guidelines for first-line treatment of advanced ESCC recommend chemotherapy containing a platinum and a paclitaxel agent. Camrelizumab demonstrated antitumor activity in the first-line treatment of advanced ESCC. This study aimed to explore the efficacy and safety of camrelizumab combined with paclitaxel and platinum in the first-line treatment of ESCC.MethodsIn this single-arm, phase II study, patients were eligible for enrollment if they had a histologically or cytologically confirmed diagnosis of locally advanced/advanced unresectable ESCC. The patients received camrelizumab (200mg, iv, q3w) in combination with chemotherapy. The chemotherapy regimen consists of paclitaxel (155mg/m2, iv, q3w) and nedaplatin (80mg/m2, iv, q3w) for 6 cycles, and the therapeutic effects were determined every 2 cycles (6 weeks). The primary endpoint was the rate of 12-month overall survival, and the secondary endpoints were objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS).ResultsFrom May 2020 to July 2021, 83 patients with a median age of 58 years (range 44–75 years) were enrolled. The median treatment duration was 87 days. Among them, 50 patients were available for efficacy analysis, of which 31 patients achieved partial response (PR), and 18 had stable disease (SD). The ORR was 62% and DCR was 98%. 33 patients were in the process of therapy and had not completed 2 cycles, and the efficacy evaluation cannot be performed yet. The adverse reactions in this study include reduction of red blood cell (20.1%), anemia (17.7%), hypomagnesemia (15.10%), fatigue (14%), thrombocytopenia (10.1%), hand-foot skin reaction (8.9%), proteinuria (7.6%), hyponatremia (6.3%), neutropenia (2.5%), reactive cutaneous capillary endothelial proliferation (10.1%) and immune pneumonia (1.2%). During the course of therapy, all adverse events (AEs) were grade 1/2, and no patient experienced grade 3/4 AEs. No patient was hospitalized because of treatment-related complications. The treatment was well tolerated and no toxic death occurred. All the AEs can be controlled and alleviated after symptomatic treatment.ConclusionsCamrelizumab in combination with paclitaxel and platinum displayed controllable security and similar therapeutic effect to other immune checkpoint inhibitors. This encouraging result promoted us to continue this phase II study.AcknowledgementsThe authors thank the patients and their families and caregivers for participating in this trial as well as all investigators and site personnel who participated in this study.Trial RegistrationChiCTR2100046355Ethics ApprovalThe study has obtained ethics approvalThe name of the ethics committee: Chinese Ethics Committee of Registering Clinical Trials Registration number:ChiCTR2100046355 The authors stated that the participants gave informed consent before taking part

Efficacy and safety of KN046 plus paclitaxel/cisplatin as first-line treatment for unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4062-4062
Author(s):  
Jianming Xu ◽  
Rongrui Liu ◽  
Yanqiao Zhang ◽  
Nong Xu ◽  
Qingxia Fan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Squamous Cell Carcinoma ◽  
Adverse Events ◽  
Esophageal Squamous Cell Carcinoma ◽  
Locally Advanced ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
First Line ◽  
Clinical Trial Information ◽  
First Line Treatment

4062 Background: The prognosis of pts with advanced esophageal squamous cell carcinoma (ESCC) remains dismal clinically. Paclitaxel and cisplatin were used as the standard first-line regimen in ESCC for almost two decades. Recently, the combination of PD-1/PD-L1 pathway blockades with chemotherapy has shown synergistic efficacy in a few clinical trials. KN046 is the world's first dual immune checkpoint inhibitor, which can block PD-1/PD-L1 and CTLA-4 pathways at the same time. The purpose of this ongoing phase II trial (NCT03925870) in China was to evaluate the efficacy and safety of KN046 monotherapy or combined with chemotherapy for unresectable locally advanced, recurrent or metastatic ESCC. Methods: This trial included 3 cohorts, one of which enrolled systemic treatment naïve pts with histologically or cytologically confirmed unresectable locally advanced, recurrent or metastatic ESCC who have ECOG PS of 0-1. Eligible subjects were given paclitaxel (135-175mg/m2, iv, d1, q3w) and cisplatin (75mg/m2, iv, d2-4, q3w) plus KN046 (5mpk, iv, d1, q3w) for 4̃6 cycles during initial therapy. For those without progressive disease, maintenance treatment was administrated with KN046 monotherapy (5mpk, iv, q2w) until progression or unacceptable toxicity. Tumour response was assessed according to RECIST 1.1 every 6 weeks. The primary endpoint was investigator-assessed ORR. Secondary endpoints included DCR, safety, PK profile, and immunogenicity. Results: As of December 14, 2020, 15 pts were enrolled, all of them were male, 52.3% ≥60 years, 64% ECOG 1, 80% with distant metastasis. Median exposure time to KN046 was 11.4 wks and average KN046 treatment was 2.4 cycles. 12 pts were included in the efficacy analysis and 15 pts in the safety analysis. The overall response rate (ORR) and disease control rate (DCR) were 58.3% and 91.6%, respectively. 7 pts (58.3%) had partial response (PR) including one complete response of target lesion. 4 pts (33.3%) had stable disease (SD) with 3 pts showing more than 20% of tumor burden reduction. The overall incidence of KN046 related adverse events was 80.0%, with 13.3% Gr 3 or above TRAE. Infusion-related adverse events occurred during 7.8% and most were mild. Immune related adverse events（irAE）were seen in 53.3% and the most common Gr 3 irAE were nausea (n＝1, 6.7%) and rash (n＝1, 6.7%). Conclusions: KN046 plus paclitaxel/cisplatin demonstrated clinical efficacy and acceptable safety as first-line treatment, and might be a favorable option for pts with advanced ESCC. Clinical trial information: NCT03925870. Research Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd. Clinical trial information: NCT03925870.

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