A multicenter open-label phase II trial to evaluate nivolumab and ipilimumab for 2nd line therapy in elderly patients with advanced esophageal squamous cell cancer (RAMONA)

TPS174 Background: Advanced esophageal squamous cell cancer (ESCC) is frequently diagnosed in elderly patients (pts) and impact of 2nd line chemotherapy is poorly defined. In line with recent data demonstrating effectiveness of checkpoint inhibitors Nivolumab (Nivo) and Ipilimumab (Ipi) in squamous cell carcinoma pts, combined Nivo/Ipi therapy will be assessed as 2nd line therapy of advanced ESCC in elderly pts. Methods: RAMONA is a multicenter open-label phase II trial (NCT03416244). Eligibility and geriatric status of the pts will be assessed by the G8 screening tool and the Deficit Accumulation Frailty Index (DAFI). Upon safety assessment after a three cycle run-in phase of Nivo (240 mg Q2W), eligible pts will be escalated to Nivo (240 mg Q2W)/Ipi (1 mg/kg Q6W) combination therapy. The other pts will remain on Nivo only. The primary objective of this trial is to demonstrate a significant survival benefit of the Nivo/Ipi combination therapy in advanced ESCC compared to historical data of standard chemotherapy regimens. Primary endpoint is overall survival (OS); secondary endpoints are tumor response, PFS, safety and quality of life (QoL). The trial has a 90% Power to detect a hazard ratio of 0.68 at a one-side significance level of alpha = 0.05 under the assumption of exponential survival. This corresponds to an increase of the 1-year OS rate by a margin of 13% compared to historical controls for standard chemotherapy (i.e. 30% vs 17%). Subjects are accrued for a period of 12 month. Follow-up continues for 24 month after the last subject is added. Including a sample size increase to compensate for uninformative drop-outs a total of n = 75 subjects will be recruited. The primary endpoint will be assessed using a one-sample log-rank test. A particular study objective is the evaluation of the tolerability of Nivo as single agent and in combination with Ipi in terms of QoL. Therefore time to QoL deterioration will be determined. 18 pts have been enrolled by mid of September 2018. RAMONA also includes translational research to identify predictive biomarkers, establish organoid cultures from tumor tissues and assess the utility of microbiome analyses for response prediction. Clinical trial information: NCT03416244.

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Capecitabine plus Oxaliplatin as a Second-Line Therapy for Advanced Biliary Tract Cancers: A Multicenter, Open-Label, Phase II Trial

Journal of Cancer ◽

10.7150/jca.37610 ◽

2019 ◽

Vol 10 (25) ◽

pp. 6185-6190

Author(s):

Seung Tae Kim ◽

Sung Yong Oh ◽

Jeeyun Lee ◽

Jung Hun Kang ◽

Hyun Woo Lee ◽

...

Keyword(s):

Biliary Tract ◽

Phase Ii ◽

Phase Ii Trial ◽

Second Line ◽

Open Label ◽

Second Line Therapy ◽

Biliary Tract Cancers ◽

Line Therapy ◽

Open Label Phase

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Nimotuzumab plus paclitaxel and cisplatin as the first line treatment for advanced esophageal squamous cell cancer: A single centre prospective phase II trial

Cancer Science ◽

10.1111/cas.12894 ◽

2016 ◽

Vol 107 (4) ◽

pp. 486-490 ◽

Cited By ~ 20

Author(s):

Ming Lu ◽

Xicheng Wang ◽

Lin Shen ◽

Jun Jia ◽

Jifang Gong ◽

...

Keyword(s):

Phase Ii ◽

Squamous Cell ◽

Phase Ii Trial ◽

Squamous Cell Cancer ◽

Cell Cancer ◽

Line Treatment ◽

First Line ◽

Single Centre ◽

Prospective Phase ◽

First Line Treatment

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8533 POSTER First Results of an Uncontrolled, Phase II Trial of Induction Chemotherapy With Cetuximab and Docetaxel-Cisplatin-5FU Followed by Cetuximab+Radiotherapy in the Responders in Locally Advanced Resectable Squamous Cell Cancer of the Head and Neck

European Journal of Cancer ◽

10.1016/s0959-8049(11)72175-x ◽

2011 ◽

Vol 47 ◽

pp. S553 ◽

Cited By ~ 2

Author(s):

E. Remenar ◽

J. Lövey ◽

P. Koltai ◽

K. Horvath ◽

M. Gödeny ◽

...

Keyword(s):

Head And Neck ◽

Induction Chemotherapy ◽

Phase Ii ◽

Squamous Cell ◽

Phase Ii Trial ◽

Squamous Cell Cancer ◽

Cell Cancer ◽

Locally Advanced ◽

First Results

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Prognostic value of systemic immune-inflammation index in elderly patients with esophageal squamous cell cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e15500 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e15500-e15500

Author(s):

Shengjun Ji ◽

Qingqing Chen

Keyword(s):

Elderly Patients ◽

Squamous Cell ◽

Roc Curve ◽

Squamous Cell Cancer ◽

Univariate Analysis ◽

Cell Cancer ◽

Esophageal Squamous Cell Cancer ◽

Optimal Threshold ◽

Predictive Index ◽

N Stage

e15500 Background: The aim is to assess the value of systemic immune-infflammation index (SII) in elderly patients with esophageal squamous cell cancer after radiotherapy. Methods: Total 128 patients larger than 65 years were included. The optimal threshold of SII was determined by establishing a receiver operating characteristic (ROC) curve, and the relationship between SII and prognosis was analyzed. Results: The ROC curve showed that the optimal threshold of the pretherapeutic SII for predicting the efficacy of radiotherapy was 700.97. Univariate analysis showed that SII was significantly associated with radiotherapy (P<0.001). The OS of the low SII group was 83.5%, 62.0%, 48.1% for 1 year, 2 years, and 3 years, respectively. The OS of the high SII group was 75.5%, 30.6%, 24.5% for 1 year, 2 years, and 3 years, respectively. The differences were statistically significant (all P<0.001). Univariate analysis showed that SII, N stage, and TNM stage were all related to the OS (all P < 0.01). Cox multivariate analysis showed that SII were independent prognostic factors. Conclusions: SII is a predictive index for elderly patients with esophageal squamous cell cancer after radiotherapy.

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