Study on Chemoradiation and Pembrolizumab Followed by Pembrolizumab and Lenvatinib Before Surgery for Non-metastatic Esophageal or Gastroesophageal Junction Cancer
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT04929392
This clinical trial is exploring a treatment plan that combines chemoradiation, pembrolizumab, and lenvatinib before surgery to treat esophageal or gastroesophageal junction cancer that hasn't spread to other parts of the body.
Patient Parameters
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Program Overview
This study is testing a treatment approach for esophageal or gastroesophageal junction cancer that hasn't spread. It involves using a combination of treatments before surgery: chemoradiation (chemotherapy and radiation therapy), pembrolizumab (an immunotherapy drug), and lenvatinib (a drug that slows cancer growth). The aim is to see if this combination can kill more cancer cells and improve outcomes for patients.
Description
The main goal of this study is to see how well the treatment can completely eliminate cancer cells 14 weeks after starting chemoradiation. Researchers will also look at how safe and tolerable pembrolizumab and lenvatinib are for patients. They will study how these drugs might boost the immune system's response to cancer and track patients' survival without the disease returning.
The study will also explore genetic changes in tumors and how these might trigger immune responses, as well as changes in the gut microbiome that could relate to treatment success.
Treatment Plan:
- Chemoradiation Phase: Patients receive chemotherapy drugs (carboplatin and paclitaxel) and radiation therapy over 6 weeks, along with pembrolizumab.
- Window Period: Patients continue with pembrolizumab and start taking lenvatinib orally for several weeks.
- Surgery/Surveillance: Patients who do not have a complete response undergo surgery. Those with a complete response may have regular check-ups instead of surgery.
After treatment, patients will have follow-up visits for up to 3 years to monitor their health.
Eligibility Criteria
Inclusion Criteria
- Must provide informed consent and agree to use previous tumor biopsy samples.
- Age 18 or older.
- Good overall health (ECOG score of 0 or 1).
- Diagnosed with non-metastatic esophageal or gastroesophageal junction cancer.
- Cancer stage I (T1N1 only) to IVA, including specific types like squamous cell or adenocarcinoma.
- Suitable for chemoradiation and surgery or regular check-ups if surgery is not pursued.
- Meet specific blood count and organ function requirements.
- Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for 120 days after the last treatment dose.
Exclusion Criteria
- Previous treatment with certain immune or cancer drugs.
- Recent radiotherapy, investigational drugs, or major surgery.
- Current use of systemic steroids or immunosuppressive medications.
- Active or untreated brain metastases.
- Certain gastrointestinal conditions or severe allergies to study drugs.
- Active autoimmune diseases needing treatment in the past 2 years.
- History of certain infections like HIV, hepatitis B or C, or tuberculosis.
- Recent diagnosis or treatment for other cancers.
- Pregnant or breastfeeding women.
- Any condition that might make it unsafe to participate or difficult to follow study procedures.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Medical Center | 91010 | Duarte | California |
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