Combination of Radiation Therapy and Peptide Specific CTL Therapy in Treating Patients With Esophageal Cancer

Esophageal Neoplasms Clinical Trial

Official title:

Phase II Study of Radiation Therapy With Peptide Specific CTL Therapy in Treating Patients With Unresectable, Advanced or Recurrent Esophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03011255
• Other study ID #: HangzhouCH06
• Status: Recruiting
• Phase: Phase 2
• First received: December 28, 2016
• Last updated: August 3, 2017
• Start date: December 2016
• Est. completion date: December 2019

Study information

• Verified date: August 2017
• Source: Hangzhou Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Immunotherapy is now considered to be one of promising approaches for treating cancer. Radiation therapy has been to be a cornerstone treatment for unresectable advanced esophageal cancer. Radiation-induced mutation genes were identified as new sources of tumor associated antigens using exon sequencing and peptide microarray technologies. Epitope peptides for these targets are able to induce peptide specific cytotoxic T lymphocytes (CTL). In this clinical trial, investigators evaluate the efficacy and safety of peptide specific CTL therapy in combination with radiation therapy in treating patients with unresectable, advanced or recurrent esophageal cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients must have unresectable, locally advanced, recurrent disease of esophageal cancer. Histologically confirmed cancer of the esophagus.

2. measurable disease by CT scan

3. ECOG performance status of 0 to 2

4. Expected survival of at least 3months

5. Laboratory values as follow:

• Absolute neutrophil count (ANC) = 1.5×109

• White blood cell count = 3×109/L

• Platelets = 100×109/L

• Haemoglobin (Hb) = 10g/dL (patients'Hb should be corrected to >10g/dL before treatment)

• Adequate liver function (within 1 week prior to randomization)

• Serum bilirubin = 1.5× ULN

• Alanine aminotransferase/aspartate transaminase (ALT / AST) = 2.5× ULN

• Alkaline phosphatase (ALP) = 3× ULN

6. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy (women of childbearing potential:Refusal or inability to use effective means of contraception)

2. Breastfeeding

3. Active or uncontrolled infection

4. Prior chemotherapy, radiation therapy or immunotherapy

5. Concurrent treatment with steroid or immunosuppressing agent

6. Patient with peptic ulcer disease

7. Other malignancy within 5 years prior to entry into the study, expect for treated non-melanoma skin cancer and cervical carcinoma in situ

8. Disease to the central nervous system

9. Decision of unsuitableness by principal investigator or physician-in-charge

Related Conditions & MeSH terms

• Digestive System Diseases
• Esophageal Diseases
• Esophageal Neoplasms
• Gastrointestinal Diseases

Intervention

Biological:
• peptide specific CTL
Radiation: RT to 60 Gy, 5 x per week,for 6 weeks Biological: Peptide specific CTL Peptide specific CTL will be administered by intravenous injection on day 28 of radiation.

Locations

Country	Name	City	State
China	Hangzhou Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Shixiu Wu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control	occurrence of local or regional progression	two years after enrollment
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Number of participants with treatment-related adverse events as assessed by Number of participants with treatment-related adverse events as assessed by treatment-related adverse events assessed by CTCAE v4.0	3 months
Secondary	Objective response rate as assessed by RECIST criteria		3 months
Secondary	Time to progression		1 year
Secondary	Overall survival		1 year