PD-1Phase 1/2NCT04061928
Toripalimab With Preoperative Chemoradiotherapy for LA-EGJ
A Phase 1/2 study testing PD-1 in people with PD-1 and Chemoradiotherapy, run by Peking University.
Trial summary
This study aims to investigate the safety and efficacy of radiotherapy combined with Toripalimab (PD-1 inhibitor) in the treatment of locally advanced adenocarcinoma of the gastroesophageal junction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- PD-1, Chemoradiotherapy, Gastroesophageal Junction Cancer
- What is being tested?
- PD-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 26 Aug 2019to 25 Aug 2023
- Phase
- Phase 1/2
- 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
- 1) Age 18-75, male and female.
- 2) ECOG score was 0-1.
- 3) Diagnosis of adenocarcinoma in the gastroesophageal junction.
- 4) Initial treatment of locally advanced patients (cT3-4 or N+, and M0).
- 5) The estimated survival time will be more than 12 months.
- 6) Adequate organ reserve function.
- 7) agree to join the group, willing to cooperate with clinical research, and sign the informed consent.
Who cannot join
- 1) Patients have received immunotherapy, such as PD-1 antibody, PD-L1 antibody and CTLA4 antibody.
- 2) Immunosuppressive drugs were used within 4 weeks before admission.
- 3) Active infection, acute myocardial infarction in recent 6 months, severe arrhythmia requiring long-term drug intervention, severe stroke, uncontrolled epilepsy or other serious medical complications.
- 4) In the past five years, there have been other malignant diseases except for cured skin cancer and cervical cancer in situ.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Combination of Toripalimab With Preoperative Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction
This study aims to investigate the safety and efficacy of radiotherapy combined with Toripalimab (PD-1 inhibitor) in the treatment of locally advanced adenocarcinoma of the gastroesophageal junction.
Read the detailed description
In this study, patients with locally advanced adenocarcinoma of gastroesophageal junction will be enrolled to explore the safety and efficacy of preoperative radiotherapy and chemotherapy combined with Toripalimab (PD-1). Around 45 patients will be recruited in this one-arm cohort. All patients in this cohort will be treated with preoperative radiotherapy and chemotherapy plus PD-1 for two times, then another two times of PD-1 before operation. After surgery, postoperative chemotherapy plus PD-1 will be carried out for four times. This study focuses on the safety of chemoradiotherapy combined with immunotherapy, and whether the TRG grade, LC, DFS have been improved.
- Conditions
- PD-1, Chemoradiotherapy, Gastroesophageal Junction Cancer
- Being tested
- PD-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1Drug
Also called Toripalimab
2 times PD-1 (240mg) combined with preoperative chemoradiotherapy，then another 2 times PD-1 before operation. 4 times PD-1 combined with postoperative chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Combination of toripalimab with preoperative chemoradiotherapy | Experimental | This is a one arm study, enrolled locally advanced EGJ patients will receive toripalimab and combined with preoperative chemoradiotherapy and operation.
generic name：PD-1 dosage form：Injection dosage：240mg (6ml) frequency：every 3 weeks duration：4 times before operation and 4 times after operation Receives: Drug: PD-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRG (Tumor Regression Grading)
The TRG of operation after neoadjuvant chemoradiotherapy and immunotherapy.
Measured: 10 days after operation
Secondary outcomes (3)
Number of participants with AEs (Adverse Events)
The AEs during the trial, including radiation mucositis, bone marrow suppression, AEs related to immunotherapy and so on
Measured: Through study completion, an average of 1 year
LC (Local Control)
The local control of the patients
Measured: Through study completion, an average of 1 year
DFS (Disease Free Survival)
The disease free survival of the patients
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start26 Aug 2019 (estimated)
- Primary completion25 Aug 2022 (estimated)
- Study completion25 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PD-1Studies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziyu Li, MD, Peking University
- Investigators
- Ziyu Li, MD, Principal investigator, Peking University Cancer Hospital & InstituteYongheng Li, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061928
- Sponsor's protocol ID
- 2019YJZ38
- Status last verified
- Aug 2019
- First submitted
- 1 Aug 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of Toripalimab With Preoperative Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction
- ClinicalTrials.gov ID
- NCT04061928
- Acronym / sponsor ID
- 2019YJZ38
- Conditions
- PD-1, Chemoradiotherapy, Gastroesophageal Junction Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 26 Aug 2019 (estimated)
- Primary completion
- 25 Aug 2022 (estimated)
- Study completion
- 25 Aug 2023 (estimated)
- First posted
- 20 Aug 2019 (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.
This study aims to investigate the safety and efficacy of radiotherapy combined with Toripalimab (PD-1 inhibitor) in the treatment of locally advanced adenocarcinoma of the gastroesophageal junction.
Detailed description
In this study, patients with locally advanced adenocarcinoma of gastroesophageal junction will be enrolled to explore the safety and efficacy of preoperative radiotherapy and chemotherapy combined with Toripalimab (PD-1). Around 45 patients will be recruited in this one-arm cohort. All patients in this cohort will be treated with preoperative radiotherapy and chemotherapy plus PD-1 for two times, then another two times of PD-1 before operation. After surgery, postoperative chemotherapy plus PD-1 will be carried out for four times. This study focuses on the safety of chemoradiotherapy combined with immunotherapy, and whether the TRG grade, LC, DFS have been improved.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination of toripalimab with preoperative chemoradiotherapy | Experimental | Drug: PD-1This is a one arm study, enrolled locally advanced EGJ patients will receive toripalimab and combined with preoperative chemoradiotherapy and operation. generic name：PD-1 dosage form：Injection dosage：240mg (6ml) frequency：every 3 weeks duration：4 times before operation and 4 times after operation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1) Age 18-75, male and female.
- 2) ECOG score was 0-1.
- 3) Diagnosis of adenocarcinoma in the gastroesophageal junction.
- 4) Initial treatment of locally advanced patients (cT3-4 or N+, and M0).
- 5) The estimated survival time will be more than 12 months.
Key exclusion criteria (4 listed)
- 1) Patients have received immunotherapy, such as PD-1 antibody, PD-L1 antibody and CTLA4 antibody.
- 2) Immunosuppressive drugs were used within 4 weeks before admission.
- 3) Active infection, acute myocardial infarction in recent 6 months, severe arrhythmia requiring long-term drug intervention, severe stroke, uncontrolled epilepsy or other serious medical complications.
- 4) In the past five years, there have been other malignant diseases except for cured skin cancer and cervical cancer in situ.
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 |
|---|---|---|
| PD-1Also: Toripalimab2 times PD-1 (240mg) combined with preoperative chemoradiotherapy，then another 2 times PD-1 before operation. 4 times PD-1 combined with postoperative chemotherapy. | Drug | Combination of toripalimab with preoperative chemoradiotherapy |
Primary outcome
TRG (Tumor Regression Grading)
Time frame: 10 days after operation
The TRG of operation after neoadjuvant chemoradiotherapy and immunotherapy.
3 secondary outcomes
Number of participants with AEs (Adverse Events)
Time frame: Through study completion, an average of 1 year
LC (Local Control)
Time frame: Through study completion, an average of 1 year
DFS (Disease Free Survival)
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Ziyu Li, MD principal investigator
Peking University Cancer Hospital & Institute
Yongheng Li, MD principal investigator
Peking University Cancer Hospital & Institute
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PD-1 in people with PD-1 and Chemoradiotherapy, run by Peking University.
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 7 inclusion and 4 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 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jianhao Geng, MD (+86-18500227857, gengjh3@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TRG (Tumor Regression Grading) (time frame: 10 days after operation). 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 20 Aug 2019.