PD-L1 Positive Locally Advanced Patients With Resectable Gastric CancerPhase 2NCT05466019
A Prospective, Single Center Clinical Study of Toripalimab Combined With FLOT Regimen for Perioperative Treatment of PD-L1 Positive Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GEJ)
A Phase 2 study testing Drug: Toripalimab, FLOT(Docetaxel+oxaliplatin+leucovorin+5-FU) in people with PD-L1 Positive Locally Advanced Patients With Resectable Gastric Cancer, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
In this study, patients with PD-L1 positive locally advanced patients with resectable gastric cancer or gastroesophageal junction adenocarcinoma were invited to participate in the study.To evaluate the efficacy and safety of patients with PD-L1 positive gastric cancer or gastroesophageal junction adenocarcinoma (≥T3… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- PD-L1 Positive Locally Advanced Patients With Resectable Gastric Cancer
- What is being tested?
- Drug: Toripalimab, FLOT(Docetaxel+oxaliplatin+leucovorin+5-FU)
- 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 May 2021to 1 Dec 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
- Informed consent of the patient;
- 18 years old <age <75 years old;
- The researcher judged that he could comply with the study protocol;
- Histologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert II-III);
- Clinical stage at admission: ≥T3 with ≥1 lymph node metastasis and no distant metastasis (AJCC 8th)
- Esophagogastroduodenoscopy must be performed
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- Diagnostic laparoscopy must be performed
- Immunohistochemistry confirmed that the patient was PD-L1 positive (CPS≥1);
- Preoperative ECOG [Using the ECOG scoring standard Zubrod-ECOG-WHO (ZPS, 5-point method) developed by the Eastern Cooperative Oncology Group (ECOG)] Physical State Score 0/1;
- Preoperative ASA score I-III;
- Expected survival ≥12 weeks;
- The baseline blood routine and biochemical parameters of selected patients should meet the following criteria:
- Hemoglobin ≥90g/ L, which can be met by blood transfusion;
- Absolute neutrophil count ≥1.5×10^9/ L
- Platelet count ≥100×10^9/ L
- Aspartic acid or alanine aminotransferase ≤ 2.5 times the upper limit
- Alkaline phosphatase ≤ 2.5 times normal upper limit (ULN),
- Thyroid stimulating hormone (TSH) ≤1 times ULN (if abnormal, T3 and T4 levels should be investigated at the same time; if T3 and T4 levels are normal, they can be included in the group);
Who cannot join
- Inestigators identified stage IV (metastatic) or unresectable gastric or gastroesophageal junction adenocarcinoma
- Previous systemic treatment for gastric cancer
- Have a history of allergy to any component of terriprizumab, oxaliplatin, capecitabine;
- Received any of the following medical treatment:
- Have received anti-PD-1 or anti-PD-L1 antibody therapy in the past; B. Have received any investigational drug treatment within 4 weeks before using the drug for the first time; C. Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; D. Receive the last dose of anti-cancer treatment (including radiotherapy) within 4 weeks before the first use of the study drug;; E. Receive systematic treatment with corticosteroids (> 10mg prednisone equivalent daily dose) or other immunosuppressants within 2 weeks prior to their first use of the study drug; F. Those who have been vaccinated with anti-tumor vaccines or the study drugs have been vaccinated with live vaccines within 4 weeks before the first administration; G. Those who have undergone major surgery or trauma within 4 weeks before using the study drug for the first time;
- History of other malignant diseases within 5 years;
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- History of active autoimmune disease or autoimmune disease
- The subject has cardiovascular clinical symptoms or disease that is not well controlled;
- Severe infection 4 weeks prior to first use of study drug (CTCAE > Level 2)
- A history of interstitial lung disease (except for radiation pneumonia not treated with Chinese hormone) or non-infectious pneumonia;
- Patients with active pulmonary tuberculosis infection found by history or CT examination, or patients with active pulmonary tuberculosis infection history within 1 year before enrollment, or patients with active pulmonary tuberculosis interference history more than 1 year ago but without formal treatment;
- Pregnant or lactating women;
- Suffering from severe mental illness.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Hospital of Jilin University
Changchun, Jilin
Quan Wang, phD, 15843073207, wquan@jlu.edu.cn
About this study
Official title: Toripalimab Combined With FLOT Regimen for Perioperative Treatment of PD-L1 Positive Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GEJ): a Prospective, Single-center Clinical Study
In this study, patients with PD-L1 positive locally advanced patients with resectable gastric cancer or gastroesophageal junction adenocarcinoma were invited to participate in the study.To evaluate the efficacy and safety of patients with PD-L1 positive gastric cancer or gastroesophageal junction adenocarcinoma (≥T3 and the number of lymph node metastasis ≥1, and No distant metastasis) using Toripalimab combined with docetaxel, oxaliplatin, fluorouracil, leucovorin (FLOT regimen) .
- Being tested
- Drug: Toripalimab, FLOT(Docetaxel+oxaliplatin+leucovorin+5-FU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: Toripalimab, FLOT(Docetaxel+oxaliplatin+leucovorin+5-FU)Drug
FLOT: Docetaxel 50mg/m2 ivd d1 + oxaliplatin 85mg/m2 ivd d1 + leucovorin 200mg/m2 ivd d1 + 5-FU 2600mg/m2 civ, Q2W Toripalimab 3mg/kg, intravenously administered on the first day of each cycle, Q2W.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab combined with FLOT regimen | Experimental | The enrolled patients will receive 3 cycles of FLOT regimen +Toripalimab treatment before surgery, and every 2 weeks is a treatment cycle (Q2W). After completing the 3 cycles of treatment, the patient undergoes surgical resection.Toripalimab combined with FLOT regimen were maintained for 4 cycles after surgery. Receives: Drug: Drug: Toripalimab, FLOT(Docetaxel+oxaliplatin+leucovorin+5-FU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR)
Measured: 3 months
Secondary outcomes (9)
event-free survival (EFS)
Measured: 2 years
disease-free survival (DFS)
Measured: 2 years
overall survival (OS)
Measured: 2 years
objective response rate (ORR)
Measured: 3 months
R0 Surgical conversion rate
Measured: 3 months
major pathological response (MPR)
Measured: 3 months
Incidence and severity of adverse events
Measured: 6 months
index of tumor-infiltrating lymphocyte (sTIL) infiltration
Measured: 3 months
type and number of intestinal flora
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 May 2021
- Primary completion1 May 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PD-L1 Positive Locally Advanced Patients With Resectable Gastric CancerStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Wang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466019
- Sponsor's protocol ID
- STARS-GC04
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toripalimab Combined With FLOT Regimen for Perioperative Treatment of PD-L1 Positive Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GEJ): a Prospective, Single-center Clinical Study
- ClinicalTrials.gov ID
- NCT05466019
- Acronym / sponsor ID
- STARS-GC04
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 20 Jul 2022 (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.
In this study, patients with PD-L1 positive locally advanced patients with resectable gastric cancer or gastroesophageal junction adenocarcinoma were invited to participate in the study.To evaluate the efficacy and safety of patients with PD-L1 positive gastric cancer or gastroesophageal junction adenocarcinoma (≥T3 and the number of lymph node metastasis ≥1, and No distant metastasis) using Toripalimab combined with docetaxel, oxaliplatin, fluorouracil, leucovorin (FLOT regimen) .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab combined with FLOT regimen | Experimental | Drug: Drug: Toripalimab, FLOT(Docetaxel+oxaliplatin+leucovorin+5-FU)The enrolled patients will receive 3 cycles of FLOT regimen +Toripalimab treatment before surgery, and every 2 weeks is a treatment cycle (Q2W). After completing the 3 cycles of treatment, the patient undergoes surgical resection.Toripalimab combined with FLOT regimen were maintained for 4 cycles after surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Informed consent of the patient;
- 18 years old <age <75 years old;
- The researcher judged that he could comply with the study protocol;
- Histologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert II-III);
- Clinical stage at admission: ≥T3 with ≥1 lymph node metastasis and no distant metastasis (AJCC 8th)
Key exclusion criteria (13 listed)
- Inestigators identified stage IV (metastatic) or unresectable gastric or gastroesophageal junction adenocarcinoma
- Previous systemic treatment for gastric cancer
- Have a history of allergy to any component of terriprizumab, oxaliplatin, capecitabine;
- Received any of the following medical treatment:
- History of other malignant diseases within 5 years;
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 |
|---|---|---|
| Drug: Toripalimab, FLOT(Docetaxel+oxaliplatin+leucovorin+5-FU)FLOT: Docetaxel 50mg/m2 ivd d1 + oxaliplatin 85mg/m2 ivd d1 + leucovorin 200mg/m2 ivd d1 + 5-FU 2600mg/m2 civ, Q2W Toripalimab 3mg/kg, intravenously administered on the first day of each cycle, Q2W. | Drug | Toripalimab combined with FLOT regimen |
Primary outcome
Pathological complete response (pCR)
Time frame: 3 months
9 secondary outcomes
event-free survival (EFS)
Time frame: 2 years
disease-free survival (DFS)
Time frame: 2 years
overall survival (OS)
Time frame: 2 years
objective response rate (ORR)
Time frame: 3 months
R0 Surgical conversion rate
Time frame: 3 months
major pathological response (MPR)
Time frame: 3 months
Incidence and severity of adverse events
Time frame: 6 months
index of tumor-infiltrating lymphocyte (sTIL) infiltration
Time frame: 3 months
type and number of intestinal flora
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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 Drug: Toripalimab, FLOT(Docetaxel+oxaliplatin+leucovorin+5-FU) in people with PD-L1 Positive Locally Advanced Patients With Resectable Gastric Cancer, run by The First Hospital of Jilin University 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 18 inclusion and 13 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 Jul 2022. 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?
Pathological complete response (pCR) (time frame: 3 months). 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 Jul 2022.