← Back to Search

Monoclonal Antibodies

Radiation Therapy for Esophageal Cancer

Phase 2

Waitlist Available

Research Sponsored by Apexigen America, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, then at time of surgery, and 3 and 6 months post-operatively

Awards & highlights

Study Summary

This trial is testing a combination of drugs and radiation to see if it can better treat esophageal cancer before surgery.

Eligible Conditions

Esophageal Cancer
Gastroesophageal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, then at time of surgery, and 3 and 6 months post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, then at time of surgery, and 3 and 6 months post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, then at time of surgery, and 3 and 6 months post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pathologic complete response (pCR) rate

Secondary outcome measures

Frequency of adverse events

Pathologic stage at time of surgery

Radiographic/metabolic response to neoadjuvant treatment on Computed Tomography (CT) / CT-Positron Emission Tomography (PET) (CT-PET)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: APX005M with chemoradiationExperimental Treatment5 Interventions

APX005M: 0.3mg/kg dose intravenously over 1 hour, every 3 weeks x 3 doses (weeks 1, 4, and 7). Treatment begins 2 weeks prior to concurrent chemoradiation (chemoRT); continues during weeks 2 and 5 of chemoRT. Daily radiation therapy (RT): 28 fractions (28 days) Chemotherapy: Carboplatin and paclitaxel will be given intravenously over 1 hour, once weekly, for 5 weeks (days 1, 8, 15 22, and 29 of RT). Carboplatin dose will be area under curve (AUC) 2. Paclitaxel dose will be 50mg/m2. Surgical resection of tumor: between weeks 10-16

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

APX005M

2017

Completed Phase 2

~350

Radiation Therapy

2017

Completed Phase 3

~7250

Paclitaxel

2011

Completed Phase 4

~5380

Carboplatin

2014

Completed Phase 3

~6670

Surgical resection of tumor

2017

Completed Phase 2

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Apexigen America, Inc.Lead Sponsor

11 Previous Clinical Trials

606 Total Patients Enrolled

Apexigen, Inc.Lead Sponsor

11 Previous Clinical Trials

606 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it dangerous to receive Radiation Therapy?

"Radiation Therapy received a safety score of 2 because, while there is some data supporting its safety, there is no evidence that it is an effective treatment."

Answered by AI

For what types of ailments is Radiation Therapy commonly used?

"Radiation therapy can be used to target and shrink melanomas, neoplasm metastases, and non-hodgkin lymphomas."

Answered by AI

Is this study also taking place in Canadian hospitals?

"Currently, this study is accepting patients from the University of Arizona, Wake Forest School of Medicine, University of California and 10 other locations."

Answered by AI

Are investigators still enrolling people into this research project?

"According to the most recent update on clinicaltrials.gov, this study is not currently looking for new patients. The trial was initially posted on October 6th, 2017 but was last edited on April 28th, 2022. Although this specific trial is not recruiting, there are 1,461 other studies that are."

Answered by AI

What other treatments have included Radiation Therapy in the past?

"As of now, 1235 clinical trials concerning radiation therapy are ongoing with 342 of them being in phase 3. Most of these trails are situated in Shanghai, but there are 66383 locations for these trials in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers

2017. "APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03165994.