Pembrolizumab Plus Paclitaxel Cisplatin Followed by Surgery for Locally Advanced ESCC

  • STATUS
    Recruiting
  • days left to enroll
    9
  • participants needed
    50
  • sponsor
    Tianjin Medical University Cancer Institute and Hospital
Updated on 19 February 2024
serum pregnancy test
pembrolizumab
squamous cell carcinoma
paclitaxel
carcinoma
urine test
squamous cell carcinoma of esophagus
pembrolizumab injection
cisplatin

Summary

The purpose of this study is to observe and evaluate the efficacy and safety of pembrolizumab plus paclitaxel, cisplatin followed by Da Vinci robot radical surgery for locally advanced esophageal squamous cell carcinoma.

Description

The Preoperative chemoradiotherapy with surgery is the standard treatment in NCCN guideline. But many patients refused or abandon radiotherapy because of the intolerable adverse effects. We designed a single-arm, open-label, phase II trial of pembrolizumab plus paclitaxel, cisplatin followed by Da Vinci robot radical surgery for locally advanced (stage III) esophageal squamous cell cancer. The purpose of this study is to observe and evaluate the efficacy and safety.

Details
Condition Esophageal Cancer, Esophageal Cancer, Squamous cell carcinoma, Squamous cell carcinoma, Stage III
Age 18years - 70years
Treatment Pembrolizumab Injection [Keytruda]
Clinical Study IdentifierNCT04389177
SponsorTianjin Medical University Cancer Institute and Hospital
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed esophageal squamous cell carcinoma
Potentially resectable cT3N1M0cT1-3N2M0(stage III)
PD-L1(+)CPS10
ECOG: 0~1
Age 18-70 years old, both men and women

Exclusion Criteria

Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer
Ineligibility or contraindication for esophagectomy
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
Has severe hypersensitivity and adverse events (Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study AnnotationsStudy Notes

Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.