Esophageal NeoplasmsPhase 2NCT03011255
Combination of Radiation Therapy and Peptide Specific CTL Therapy in Treating Patients With Esophageal Cancer
A Phase 2 study testing peptide specific CTL in people with Esophageal Neoplasms and Esophageal Diseases, run by Shixiu Wu at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Neoplasms, Esophageal Diseases, Digestive System Diseases
- What is being tested?
- peptide specific CTL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have unresectable, locally advanced, recurrent disease of esophageal cancer. Histologically confirmed cancer of the esophagus.
- measurable disease by CT scan
- ECOG performance status of 0 to 2
- Expected survival of at least 3months
- Laboratory values as follow:
- Absolute neutrophil count (ANC) ≥ 1.5×109
Show all 14Show fewer
- 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
- Able and willing to give valid written informed consent
Who cannot join
- Pregnancy (women of childbearing potential:Refusal or inability to use effective means of contraception)
- Breastfeeding
- Active or uncontrolled infection
- Prior chemotherapy, radiation therapy or immunotherapy
- Concurrent treatment with steroid or immunosuppressing agent
- Patient with peptic ulcer disease
Show all 9Show fewer
- Other malignancy within 5 years prior to entry into the study, expect for treated non-melanoma skin cancer and cervical carcinoma in situ
- Disease to the central nervous system
- Decision of unsuitableness by principal investigator or physician-in-charge
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310000
Shixiu Wu, MD, +8657186826086, wushixiu@medmail.com.cn
About this study
Official title: Phase II Study of Radiation Therapy With Peptide Specific CTL Therapy in Treating Patients With Unresectable, Advanced or Recurrent Esophageal Cancer
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.
- Being tested
- peptide specific CTL
- Keywords
- Esophageal cancer, Peptide specific CTL, Radiation
- Medical subject headings
- Esophageal Neoplasms, Esophageal Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peptide specific CTLBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| peptide specific CTL arm | Experimental | peptide specific CTL, radiation Receives: Biological: peptide specific CTL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control
occurrence of local or regional progression
Measured: two years after enrollment
Secondary outcomes (4)
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
Measured: 3 months
Objective response rate as assessed by RECIST criteria
Measured: 3 months
Time to progression
Measured: 1 year
Overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionAug 2017 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shixiu Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shixiu Wu, Hangzhou Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011255
- Sponsor's protocol ID
- HangzhouCH06
- Status last verified
- Aug 2017
- First submitted
- 28 Dec 2016
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Radiation Therapy With Peptide Specific CTL Therapy in Treating Patients With Unresectable, Advanced or Recurrent Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03011255
- Acronym / sponsor ID
- HangzhouCH06
- Keywords
- Esophageal cancer, Peptide specific CTL, Radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shixiu WuUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| peptide specific CTL arm | Experimental | Biological: peptide specific CTLpeptide specific CTL, radiation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have unresectable, locally advanced, recurrent disease of esophageal cancer. Histologically confirmed cancer of the esophagus.
- measurable disease by CT scan
- ECOG performance status of 0 to 2
- Expected survival of at least 3months
- Laboratory values as follow:
Key exclusion criteria (9 listed)
- Pregnancy (women of childbearing potential:Refusal or inability to use effective means of contraception)
- Breastfeeding
- Active or uncontrolled infection
- Prior chemotherapy, radiation therapy or immunotherapy
- Concurrent treatment with steroid or immunosuppressing agent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peptide specific CTLRadiation: 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. | Biological | peptide specific CTL arm |
Primary outcome
Local control
Time frame: two years after enrollment
occurrence of local or regional progression
4 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 3 months
Objective response rate as assessed by RECIST criteria
Time frame: 3 months
Time to progression
Time frame: 1 year
Overall survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Esophageal Neoplasms
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing peptide specific CTL in people with Esophageal Neoplasms and Esophageal Diseases, run by Shixiu Wu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control (time frame: two years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2017.