Adenocarcinoma of Esophagogastric JunctionPhase 2KEYSTONE-003NCT04813523
Pembrolizumab Plus Neoadjuvant Chemotherapy for Locally Advanced EGJ Adenocarcinoma
A Phase 2 study testing Pembrolizumab Injection [Keytruda] in people with Adenocarcinoma of Esophagogastric Junction and Neoadjuvant Chemotherapy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The purpose of this study is to observe and evaluate the efficacy and safety of pembrolizumab plus cisplatin and 5-fluorouracil (5-FU) followed Surgery for locally advanced adenocarcinoma of esophagogastric junction Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adenocarcinoma of Esophagogastric Junction, Neoadjuvant Chemotherapy, Pembrolizumab
- What is being tested?
- Pembrolizumab Injection [Keytruda]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 31 Mar 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed AEG, Siewert type I or II;
- Potentially resectable cT3-4a, any N, M0 (AJCC 8 TNM classification);
- Have a performance status of 0 or 1 on the ECOG Performance Scale;
- Age 18-75 years old, both men and women;
- Be willing and able to provide written informed consent/assent for the trial;
- Demonstrate adequate organ function , all screening labs should be performed within 10 days of treatment initiation;
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
- Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. Newly-obtained is defined as a specimen obtained up to 4 weeks (28 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
Who cannot join
- Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for AEG;
- Ineligibility or contraindication for esophagectomy;
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug;
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs);
- Has severe hypersensitivity and adverse events (≥Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Hongjing Jiang, MD,PhD, 8618622221069, jianghongjing@tmu.edu.cn
Xiaofeng Duan, MD,PhD, 8613752437179, xduan@tmu.edu.cn
About this study
Official title: Efficacy and Safety of Pembrolizumab Plus Neoadjuvant Chemotherapy With Cisplatin and 5-Fluorouracill Followed by Surgery in Patients With Locally Advanced Adenocarcinoma of Esophagogastric Junction
The purpose of this study is to observe and evaluate the efficacy and safety of pembrolizumab plus cisplatin and 5-fluorouracil (5-FU) followed Surgery for locally advanced adenocarcinoma of esophagogastric junction
Read the detailed description
The neoadjuvant chemotherapy/chemoradiotherapy with surgery is the standard treatment in NCCN guideline. But many patients refused or abandon radiotherapy because of the intolerable adverse effects. We designed a single-arm, open-label, phase II trial of pembrolizumab plus cisplatin and 5-fluorouracil (5-FU) followed by radical surgery for locally advanced adenocarcinoma of esophagogastric junction. The purpose of this study is to observe and evaluate the efficacy and safety.
- Being tested
- Pembrolizumab Injection [Keytruda]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab Injection [Keytruda]Drug
Also called Cisplatin, 5-FU
Neoadjuvant period: pembrolizumab 200mg IV, Q3W with three cycles. Adjuvant period: pembrolizumab 200 mg IV, Q3W, up to one year, which should be performed within 3-6 weeks after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Pembrolizumab+Cisplatin+5-FU | Experimental | Participants receive preoperative pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W), cisplatin 80 mg/m^2 IV Q3W, and 5-FU 600 mg/m^2/day IV infusion on Days 1 to 5. There are 3 cycels of preoprative therapy and 3 cycles of postoperative therapy. Receives: Drug: Pembrolizumab Injection [Keytruda] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathologic response (MPR)
Viable tumor comprised ≤ 10% of resected tumor specimens
Measured: one month after surgery
Secondary outcomes (3)
Progression-free survival (PFS)
Time from the enrollment to disease relapse after complete resection or death from any cause
Measured: 24 months
Overall survival (OS)
Time from the enrollment to death of any cause
Measured: 24 months
Pathologic complete response (pCR)
No tumor residue of resected tumor specimens
Measured: one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of Esophagogastric JunctionStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813523
- Sponsor's protocol ID
- TianjinCIH20210169
- Acronym
- KEYSTONE-003
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pembrolizumab Plus Neoadjuvant Chemotherapy With Cisplatin and 5-Fluorouracill Followed by Surgery in Patients With Locally Advanced Adenocarcinoma of Esophagogastric Junction
- ClinicalTrials.gov ID
- NCT04813523
- Acronym / sponsor ID
- KEYSTONE-003 / TianjinCIH20210169
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 24 Mar 2021 (actual)
- 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.
The purpose of this study is to observe and evaluate the efficacy and safety of pembrolizumab plus cisplatin and 5-fluorouracil (5-FU) followed Surgery for locally advanced adenocarcinoma of esophagogastric junction
Detailed description
The neoadjuvant chemotherapy/chemoradiotherapy with surgery is the standard treatment in NCCN guideline. But many patients refused or abandon radiotherapy because of the intolerable adverse effects. We designed a single-arm, open-label, phase II trial of pembrolizumab plus cisplatin and 5-fluorouracil (5-FU) followed by radical surgery for locally advanced adenocarcinoma of esophagogastric junction. The purpose of this study is to observe and evaluate the efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Pembrolizumab+Cisplatin+5-FU | Experimental | Drug: Pembrolizumab Injection [Keytruda]Participants receive preoperative pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W), cisplatin 80 mg/m^2 IV Q3W, and 5-FU 600 mg/m^2/day IV infusion on Days 1 to 5. There are 3 cycels of preoprative therapy and 3 cycles of postoperative therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed AEG, Siewert type I or II;
- Potentially resectable cT3-4a, any N, M0 (AJCC 8 TNM classification);
- Have a performance status of 0 or 1 on the ECOG Performance Scale;
- Age 18-75 years old, both men and women;
- Be willing and able to provide written informed consent/assent for the trial;
Key exclusion criteria (5 listed)
- Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for AEG;
- Ineligibility or contraindication for esophagectomy;
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug;
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs);
- Has severe hypersensitivity and adverse events (≥Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors.
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 |
|---|---|---|
| Pembrolizumab Injection [Keytruda]Also: Cisplatin, 5-FUNeoadjuvant period: pembrolizumab 200mg IV, Q3W with three cycles. Adjuvant period: pembrolizumab 200 mg IV, Q3W, up to one year, which should be performed within 3-6 weeks after surgery. | Drug | Experimental: Pembrolizumab+Cisplatin+5-FU |
Primary outcome
Major pathologic response (MPR)
Time frame: one month after surgery
Viable tumor comprised ≤ 10% of resected tumor specimens
3 secondary outcomes
Progression-free survival (PFS)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Pathologic complete response (pCR)
Time frame: one month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
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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 Pembrolizumab Injection [Keytruda] in people with Adenocarcinoma of Esophagogastric Junction and Neoadjuvant Chemotherapy, run by Tianjin Medical University Cancer Institute and Hospital 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 8 inclusion and 5 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 24 Mar 2021. 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?
Contact Hongjing Jiang, MD, PhD (8618622221069, jianghongjing@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathologic response (MPR) (time frame: one month after surgery). 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 24 Mar 2021.