Safety and Efficacy of Pembrolizumab in Combination With FLOT About Gastroesophageal Junction Cancer:

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
Sponsorxiaohua li

About this trial

At present, surgery is still the main treatment for gastroesophageal junction cancer. At the same time, multimodal comprehensive treatment such as chemotherapy and molecular targeted therapy can effectively alleviate pathological progression, facilitate R0 resection and improve the overall survival of patients.Pembrolizumab, as a PD-1 inhibitor, has been shown to have antitumor activity and a manageable safety profile in gastroesophageal junction cancer.Pembrolizumab combined with chemotherapy has become a research hotspot. However, to date, there is no clinical study related to gastroesophageal junction cancer. In this study, Pembrolizumab combined with FLOT was used as the first-line treatment for gastroesophageal junction cancer, aiming to explore the experience chemotherapy mode for gastroesophageal junction cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1) aged from 18 to 75 years old, including 18 and 80 years old;

Disqualifiers

1) receiving anti-tumor therapy before enrollment, including but not limited to PD-1 inhibitors, CTLA-4 antibodies, EGFR monoclonal antibodies, EGFR-Tkis, and anti-angiogenic drugs;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pembrolizumab plus chemotherapy (FLOT)

    Drug

    The experimental group was treated with pembrolizumab combined with FLOT, and the control group was treated with FLOT chemotherapy alone

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Pembrolizumab plus chemotherapy (FLOT)Experimental treatment 1 intervention
Group B: chemotherapy (FLOT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

objective response rate

objective response rate

Time frame
3 year

Secondary outcomes

1

duration of response

duration of response

Time frame
1 year
2

disease control rate

disease control rate

Time frame
1 year
3

time to response

time to response

Time frame
1 year
4

overall surival

overall surival

Time frame
5 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

xiaohua li

Lead sponsor

Xijing Hospital of Digestive Diseases

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: