The Ave-CRT Study for Newly Diagnosed Metastatic Esophageal Squamous Cell Carcinoma

NCT03800953 | Unknown Phase 2

• 1 other identifier: 201809084MIPC
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single institutional, single arm, open labeled phase II study to assess the overall radiographic response of adding Avelumab to chemotherapy and palliative radiotherapy in patients with metastatic advanced esophageal squamous cell carcinoma.

Conditions

Esophageal Tumor; Metastatic Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• overall radiographic response

  overall radiographic response at six-month will be determined by iRECIST

  6 months

Secondary Outcomes (6)

• Best radiographic response

  up to 2 years

• Progression-free survival

  up to 2 years

• Overall survival

  up to 2 years

• Frequency of adverse events

  up to 2 years

• Heath-related quality of life

  up to 2 years

Study Arms (1)

Avelumab (Bavencio)

EXPERIMENTAL

This is a single arm, and open label study. All the subjects recruited will receive Avelumab.

Drug: Avelumab

Interventions

Avelumab DRUG

The study treatment comprises two phases, the concurrent immune-chemoradiotherapy (Ave-PF-CRT) phase and the immune-chemotherapy (Ave-PF) phase. All the subjects will receive Avelumab at both phases.

Also known as: Bavencio

Avelumab (Bavencio)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proved squamous cell carcinoma of esophagus
• Metastatic disease, which are defined by TNM system of American Joint Committee on Cancer (AJCC) Cancer Staging System (8th edition) in 2017, involving distant lymph node (para-aortic or cervical) metastasis and/or visceral metastasis (lung, liver) documented by radiological examinations
• Age ≥ 20 years
• ECOG Performance Status 0 or 1
• Adequate bone marrow reserves within 2 weeks prior to registration, defined as:a. absolute neutrophil count (ANC) ≥ 1.5×109/L (1,500/μl)b. platelets ≥ 100×109/L (100,000/µl)c. hemoglobin ≥ 9.0 g/dl (may have been transfused)
• Adequate liver function reserves within 2 weeks prior to registration, defined as:
• hepatic transaminases (AST and ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 × ULN for subjects with documented metastatic disease to liver
• serum total bilirubin ≤ 2.5 × upper limit of normal (ULN)
• Adequate renal function within 2 weeks prior to registration: Creatinine ≤1.5 mg/dL
• Negative serum or urine pregnancy test for women of childbearing potential
• Women of childbearing potential and male participants must practice highly effective contraception throughout the study and for at least 30 days after last avelumab treatment administration if the risk of conception exists
• Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent

You may not qualify if:

• Patients fulfill any of the following criteria will be excluded from this trial
• Prior radiotherapy to head and neck, chest, or abdomen
• Tumor invasion to adjacent structures (T4 lesion)
• Adenocarcinoma of esophagus or gastroesophageal junction.
• No measurable metastatic target lesion(s) by RECIST criteria
• Synchronously or metachronously diagnosed squamous cell carcinoma of aerodigestive way, other than esophageal cancer
• Prior invasive malignancy
• Prior organ transplantation including allogenic stem-cell transplantation
• Current use of immunosuppressive medication, EXCEPT for the following:
• intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
• systemic corticosteroids at physiologic doses '≤ 10 mg/day of prednisone or equivalent
• steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
• Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
• Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:
• Uncontrolled active infection requiring intravenous antibiotics at the time of registration

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital, Taiwan

Taipei, Taiwan

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma

Interventions

avelumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Study Officials

• Chia-Hsien Cheng

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 11, 2019
• Study Start: March 20, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: September 8, 2021

Record last verified: 2020-11

Locations

TW (1)