Unresectable, locally-advanced esophageal squamous cell carcinoma
Conditions
Interventions
Pembrolizumab + FP therapy is administered for 4 cycles, with each cycle consisting of 3 weeks.
Pembrolizumab (200 mg/body) is administered on day 1 of each cycle.
Fluorouracil (800 mg/m^2) is adminis
Sponsors
Kotani Daisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Squamous cell carcinoma, adenosquamous cell carcinoma, or basaloid carcinoma. 2. Primary lesion located in the thoracic esophagus (UICC-TNM 8th edition). 3. Unable to undergo a macroscopically curative resection. 4. No metastases other than supraclavicular lymph node metastases. 5. 18 years old or older on the date of enrollment. 6. ECOG PS: 0 or 1. 7. Whether or not there are measurable lesions is irrelevant. 8. No treatment history for esophageal cancer other than endoscopic treatment. 9. No history of radiotherapy for the area that overlaps with the radiation field used in this study treatment. 10. Latest lab within 28 days before enrollment meet the specified values. 11. Wish to receive treatment including surgical resection after induction therapy. 12. Written consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1. History of allergy to pembrolizumab, cisplatin or fluorouracil. 2. Active hepatitis B (HBs antigen positive) or hepatitis C (HCV antibody positive). 3. Active infection requiring systemic treatment (excluding local infection). 4. Clinically significant cardiac disease, interstitial pneumonia, poorly controlled diabetes or hypertension. 5. History of other malignancies within 3 years prior to enrollment (exclucing cancers to be cured by local treatment, non-metastatic prostate cancer without requiring systemic chemotherapy or other malignancies that do not require treatment or are expected to not be adversely affected by the treatment in this study). 6. Pregnant or breastfeeding women, or men whose partners wish to be pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two-year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. R0 resection rate 2. Pathological complete response rate 3. Major pathological response 4. Progression-free survival 5. Overall survival 6. Distant metastasis-free survival 7. Recurrence pattern and rate 8. Efficacy by CPS 9. Rate of adverse events 10. Rate of perioperative complications 11. Rate of serious adverse events | — |
Contacts
Public ContactDai Okemoto
National Cancer Center Hospital East
Outcome results
None listed