Locally Advanced Gastric AdenocarcinomaPhase 2NCT04908566
Immune Checkpoint Inhibitor PD-1 Antibody Combined With Chemotherapy in the Perioperative Treatment of Locally Advanced Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing PD-1 antibody combined with FOLFIRINOX regimen and PD-1 antibody combined with SOX program in people with Locally Advanced Gastric Adenocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The FOLFIRINOX regimen has become the standard treatment regimen for advanced colorectal cancer, advanced pancreatic cancer and postoperative adjuvant treatment for pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Gastric Adenocarcinoma
- What is being tested?
- PD-1 antibody combined with FOLFIRINOX regimen and PD-1 antibody combined with SOX program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- May 2021to Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- At least 18 years of age, 75 years of age or less, no gender limitation;
- Patients with untreated locally advanced resectable adenocarcinoma of the stomach or gastroesophageal junction, with clear pathological diagnosis;
- According to RECIST 1.1, the efficacy evaluation standard for solid tumors, there were definite measurable and evaluable lesions, with spiral CT lesions ≥1cm；
- Physical condition score KPS score 80-100 points ；
- Able to receive systemic chemotherapy;
- No obvious active bleeding;
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- No history of other malignancies, except cured carcinoma in situ of the cervix, basal carcinoma of the skin or squamous cell carcinoma;
- Women of childbearing age had negative pregnancy test and had voluntarily taken effective and reliable contraceptive measures during the clinical trial；
- Sign the informed consent form voluntarily；
Who cannot join
- There are distant metastasis or local invasion of adjacent organs；
- Tumor recurrence;
- Suffered from or had previously suffered from autoimmune diseases;
- Past organ transplantation or HIV patients;
- Allergic to 5-fluorouracil, calcium leucoin, oxaliplatin, or irinotecan, or contraindications to 5-fluorouracil, calcium leucoin, oxaliplatin, or irinotecan exist;
- Malignant secondary disease dating back to 5 years (exceptions: carcinoma in situ of the cervix, adequately treated basal cell carcinoma of the skin)；
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- Severe non-surgical complications or acute infections；
- Peripheral polyneuropathy>NCI Grad I；
- Impaired blood system, liver and kidney function. The evaluation criteria are as follows:
- Blood routine: white blood cells (WBC) <3.0×109/L, neutrophils (ANC) <1.5×109/L, platelets (PLT) <100×109/L, hemoglobin (Hb) <90g/L.
- Liver and kidney function: total bilirubin (TBIL)>1.5 times the upper limit of the normal value; urea nitrogen (BUN)>1.5 times the upper limit of the normal value；Creatinine (Cr)>1.5 times the upper limit of the normal value；Alanine aminotransferase and aspartate aminotransferase (ALT and AST)> 3 times the upper limit of the normal value (without liver metastasis)；Alanine aminotransferase and aspartate aminotransferase (ALT and AST)> 5 times the upper limit of the normal value (for liver metastases)；
- Subjects with symptomatic brain metastases;
- Subjects with obvious clinical manifestations of arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, and severe valvular disease;
- Subjects with severe bone marrow failure;
- Psychotic subjects who are difficult to control；
- Pregnant or lactating subjects;
- Subjects whom the investigator considers inappropriate to participate in this trial；
- Include in another clinical trial；
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
RuiLiu
Tianjin, Tianjin Municipality, 300060
Rui Liu, (022)23340123 ext. 6012, ec_tjcih@126.com
About this study
Official title: Immune Checkpoint Inhibitor PD-1 Antibody Combined With Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX) Regimen vs. PD-1 Antibody Combined With Oxaliplatin, Tigio (SOX) Regimen During Perioperative Period A Randomized Controlled Phase II Clinical Study for the Treatment of Locally Advanced Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
The FOLFIRINOX regimen has become the standard treatment regimen for advanced colorectal cancer, advanced pancreatic cancer and postoperative adjuvant treatment for pancreatic cancer. With the continuous exploration of Chinese scholars, it has also revised the modified dose suitable for the physical fitness of the Chinese people, which is well tolerated and has a clear efficiency. The drugs in this program are all standard treatment drugs for gastric cancer.
In 2020, JAMA Network Open and JAMA Oncology successively reported the application of FOLFIRINOX in the perioperative period of gastric cancer and the late-stage results of gastric cancer, and they obtained very amazing data respectively.
Read more
According to the results of CheckMate-649, the FDA approved Nivolumab combined chemotherapy for first-line treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, regardless of PD-L1 expression. At the same time, this is also the first first-line immunotherapy approved by the FDA for gastric cancer.However, there is no definite conclusion about the preoperative neoadjuvant or perioperative clinical research, so it is necessary to explore the efficacy of PD-1 antibody in the perioperative period.
This study is a single-center, randomized, controlled phase II clinical study. The primary endpoint of the study is the perioperative administration of mFOLFIRINOX regimen combined with PD-1 antibody and D2 radical resection for the treatment of resectable advanced gastric cancer. The deep tumor remission rate (TRG0 and TRG1) , secondary endpoints include pCR rate, 3-year DFS rate, safety, R0 resection rate, D2 radical resection rate, 5-year DFS rate, 5-year OS rate.
- Conditions
- Locally Advanced Gastric Adenocarcinoma
- Being tested
- PD-1 antibody combined with FOLFIRINOX regimen, PD-1 antibody combined with SOX program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 antibody combined with FOLFIRINOX regimenDrug
Give 240 mg of PD-1 antibody before each cycle of chemotherapy, d1; Chemotherapy regimen: irinotecan 150mg/m2, d1; fluorouracil 2400 mg/m², d1-2, continuous pumping for 46 hours; leucovorin 200 mg/m², d1; oxaliplatin 65 mg/m², d1; PD-1 antibody repeats once every 3 weeks; Chemotherapy is repeated every 2 weeks. 4 cycles before surgery. 4 cycles after operation。
PD-1 antibody combined with SOX programDrug
Give 240 mg of PD-1 antibody before each cycle of chemotherapy, d1; Chemotherapy regimen: oxaliplatin 130 mg/m², d1, ticgio 40-60mg bid, d1-14 q3w;Repeat once every 3 weeks.
2-4 cycles before surgery. The perioperative period was 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| PD-1 antibody combined with FOLFIRINOX regimen | Experimental | Not described Receives: Drug: PD-1 antibody combined with FOLFIRINOX regimen |
| PD-1 antibody combined with SOX program | Active comparator | Not described Receives: Drug: PD-1 antibody combined with SOX program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response(MPR)
Measured: Surgery
Secondary outcomes (3)
Pathological complete response(pCR)
Measured: Surgery
Disease-free survival(DFS) rate of 3 years
Time to relapse or progression of disease (PD) or death from any cause within 3 years from subject screening to first recorded
Measured: progression of disease (PD) or death from any cause within 3 years
Disease-free survival(DFS) rate of 5 years
Time to relapse or progression of disease (PD) or death from any cause within 5 years from subject screening to first recorded
Measured: progression of disease (PD) or death from any cause within 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study startMay 2021 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Gastric AdenocarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908566
- Sponsor's protocol ID
- TJGI-002
- Status last verified
- Mar 2021
- First submitted
- 27 Apr 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Checkpoint Inhibitor PD-1 Antibody Combined With Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX) Regimen vs. PD-1 Antibody Combined With Oxaliplatin, Tigio (SOX) Regimen During Perioperative Period A Randomized Controlled Phase II Clinical Study for the Treatment of Locally Advanced Resectable Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04908566
- Acronym / sponsor ID
- TJGI-002
- Conditions
- Locally Advanced Gastric Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 1 Jun 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 FOLFIRINOX regimen has become the standard treatment regimen for advanced colorectal cancer, advanced pancreatic cancer and postoperative adjuvant treatment for pancreatic cancer. With the continuous exploration of Chinese scholars, it has also revised the modified dose suitable for the physical fitness of the Chinese people, which is well tolerated and has a clear efficiency. The drugs in this program are all standard treatment drugs for gastric cancer.
In 2020, JAMA Network Open and JAMA Oncology successively reported the application of FOLFIRINOX in the perioperative period of gastric cancer and the late-stage results of gastric cancer, and they obtained very amazing data respectively.
According to the results of CheckMate-649, the FDA approved Nivolumab combined chemotherapy for first-line treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, regardless of PD-L1 expression. At the same time, this is also the first first-line immunotherapy approved by the FDA for gastric cancer.However, there is no definite conclusion about the preoperative neoadjuvant or perioperative clinical research, so it is necessary to explore the efficacy of PD-1 antibody in the perioperative period.
This study is a single-center, randomized, controlled phase II clinical study. The primary endpoint of the study is the perioperative administration of mFOLFIRINOX regimen combined with PD-1 antibody and D2 radical resection for the treatment of resectable advanced gastric cancer. The deep tumor remission rate (TRG0 and TRG1) , secondary endpoints include pCR rate, 3-year DFS rate, safety, R0 resection rate, D2 radical resection rate, 5-year DFS rate, 5-year OS rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD-1 antibody combined with FOLFIRINOX regimen | Experimental | Drug: PD-1 antibody combined with FOLFIRINOX regimen |
| PD-1 antibody combined with SOX program | Active comparator | Drug: PD-1 antibody combined with SOX program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years of age, 75 years of age or less, no gender limitation;
- Patients with untreated locally advanced resectable adenocarcinoma of the stomach or gastroesophageal junction, with clear pathological diagnosis;
- According to RECIST 1.1, the efficacy evaluation standard for solid tumors, there were definite measurable and evaluable lesions, with spiral CT lesions ≥1cm；
- Physical condition score KPS score 80-100 points ；
- Able to receive systemic chemotherapy;
Key exclusion criteria (18 listed)
- There are distant metastasis or local invasion of adjacent organs；
- Tumor recurrence;
- Suffered from or had previously suffered from autoimmune diseases;
- Past organ transplantation or HIV patients;
- Allergic to 5-fluorouracil, calcium leucoin, oxaliplatin, or irinotecan, or contraindications to 5-fluorouracil, calcium leucoin, oxaliplatin, or irinotecan exist;
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-1 antibody combined with FOLFIRINOX regimenGive 240 mg of PD-1 antibody before each cycle of chemotherapy, d1; Chemotherapy regimen: irinotecan 150mg/m2, d1; fluorouracil 2400 mg/m², d1-2, continuous pumping for 46 hours; leucovorin 200 mg/m², d1; oxaliplatin 65 mg/m², d1; PD-1 antibody repeats once every 3 weeks; Chemotherapy is repeated every 2 weeks. 4 cycles before surgery. 4 cycles after operation。 | Drug | PD-1 antibody combined with FOLFIRINOX regimen |
| PD-1 antibody combined with SOX programGive 240 mg of PD-1 antibody before each cycle of chemotherapy, d1; Chemotherapy regimen: oxaliplatin 130 mg/m², d1, ticgio 40-60mg bid, d1-14 q3w;Repeat once every 3 weeks. 2-4 cycles before surgery. The perioperative period was 8 cycles. | Drug | PD-1 antibody combined with SOX program |
Primary outcome
Major pathological response(MPR)
Time frame: Surgery
3 secondary outcomes
Pathological complete response(pCR)
Time frame: Surgery
Disease-free survival(DFS) rate of 3 years
Time frame: progression of disease (PD) or death from any cause within 3 years
Disease-free survival(DFS) rate of 5 years
Time frame: progression of disease (PD) or death from any cause within 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Individual participant dataSharing planned: Yes
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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.
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 PD-1 antibody combined with FOLFIRINOX regimen and PD-1 antibody combined with SOX program in people with Locally Advanced Gastric Adenocarcinoma, 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 9 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 1 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Lliu, Doctor of Oncology (022-23341023 ext. 6012, ec_tjcih@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response(MPR) (time frame: 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 1 Jun 2021.