GC/GEJCPhase 2NCT06684158
Mecapegfilgrastim Combined With Adebrelimab and Chemotherapy as Neoadjuvant Therapy in Resectable GC/GEJC
A Phase 2 study testing Mecapegfilgrastim, Adebrelimab and Docetaxel in people with GC/GEJC, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study is a prospective, randomized ，multicencter, phase II clinical trial that aims to enroll patients with locally advanced gastric adenocarcinoma who have not received any prior treatment and are candidates for surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- GC/GEJC
- What is being tested?
- Mecapegfilgrastim, Adebrelimab and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2024to 1 Dec 2027
- 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
- 1.Subjects aged 18-75 years (including 18 and 75 years old);
- 2.Subjects who understand the study procedures and content, and voluntarily sign the written informed consent form;
- 3.Subjects with HER2-negative or HER2 status unknown gastric or gastroesophageal junction adenocarcinoma, clinically staged as T3-4a/N+M0 locally advanced gastric cancer by ultrasound gastroscopy, CT/MRI and other imaging evaluations.
- 4.Subjects who have not received prior systemic therapy.
- 5.Subjects with Eastern Cooperative Oncology Group Performance Status score (ECOG PS score): 0-1;
- 6.Subjects with life expectancy ≥ 12 months;
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- 7.Subjects with good major organ function, that is, the relevant investigation indicators within 14 days before enrollment meet the following requirements: haemoglobin ≥ 90 g/L ; neutrophil count > 1.5 × 109/L; platelet count ≥ 100 × 109/L; total bilirubin ≤ 1.5 × ULN (upper limit of normal); alanine transaminase (ALT) or aspartate transaminases (AST) ≤ 2.5 × ULN; endogenous creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula); cardiac ultrasound doppler assessment: left ventricular ejection fraction (LVEF) ≥ 50%;
- 8.Subjects with thyroid function indicators: thyroid stimulating hormone (TSH), free thyroxine (FT3/FT4) within the normal range or with slight and clinically insignificant abnormalities;
- 9.Subjects weighing more than 40 kg, or with BMI > 18.5;
Who cannot join
- 1.Subjects with a history of or concurrent with other tumors malignant, except for cured early-stage tumors, including basal cell carcinoma of the skin and carcinoma in situ of the cervix, and early-stage tumors such as stage I lung cancer and stage I rectal cancer that have received radical treatment and are judged by the investigator not to affect the subject's life in the short term.
- 2.Subjects who have participated in other drug clinical studies within 4 weeks;
- 3.Subjects with a history of haemorrhage, the severity of any grade ≥ 3 haemorrhage event according to CTCAE 5.0 criteria within 4 weeks prior to screening;
- 4.Prior to screening, there were known highly suspected distant metastases, such as suspected peritoneal nodules, suspected cancerous ascites, and no laparoscopic confirmation;
- 5.Subjects with hypertension that cannot be well controlled with single-drug therapy (blood pressure systolic > 140 mmHg, blood pressure diastolic > 90 mmHg); subjects with a history of unstable angina pectoris; subjects newly diagnosed with angina pectoris within 3 months before screening or with myocardial infarction within 6 months before screening; arrhythmia (including QTcF: male ≥ 450 ms, female ≥ 470 ms) requiring long-term use of antiarrhythmic drugs and New York Heart Association class ≥ II cardiac insufficiency;
- 6.Subjects with long-term unhealed wounds or incompletely healed fractures;
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- 7.Subjects whose imaging shows that the tumor has invaded the periphery of major blood vessels, or the investigator judges that the subject's tumor has a very high possibility of invading major blood vessels during treatment, causing fatal haemorrhage;
- 8.Subjects with abnormal coagulation function and haemorrhagic diathesis (must meet the following criteria within 14 days before enrollment: INR within the normal range without the use of anticoagulants); subjects treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues; low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (daily dose not exceeding 100 mg) is allowed for prophylactic purposes, provided that the international normalized ratio (INR) of prothrombin time is ≤ 1.5;
- 9.Subjects with a history of arterial/venous thrombotic events within 6 months prior to screening, such as cerebrovascular accident (including transient ischaemic attack), deep vein thrombosis (excluding venous thrombosis caused by previous chemotherapy catheterization that has been judged to be cured by the investigator) and pulmonary embolism, etc.;
- 10.Subjects whose urinalysis test showing protein urine ≥ ++ and confirmed 24-hour protein urine quantification > 1.0 g;
- 11.Subjects with a history of immune targeted therapy;
- 12.Subjects with a history of immunodeficiency, or suffering from other acquired or immunodeficiency congenital diseases, or history of organ transplant;
- 13.Subjects with pneumonia, non-infectious pneumonia, interstitial pneumonia and other subjects who need to use corticosteroids;
- 14.Subjects with a history of severe chronic autoimmune diseases, such as systemic lupus erythematosus; a history of inflammatory bowel disease such as ulcerative enteritis, Crohn's disease; a history of chronic diarrheal diseases such as irritable bowel syndrome; a history of nodular disease or tuberculosis; active hepatitis B, hepatitis C, and HIV infection; well-controlled non-serious immune diseases such as dermatitis, arthritis, and psoriasis can be enrolled. Subjects with a hepatitis B virus titer < 2000 copy/mL can be enrolled.
- 15.Subjects with hypersensitivity to humanized or murine monoclonal antibodies;
- 16.Subjects with a history of mental drug abuse who are unable to abstain or who have a mental disorder;
- 17.Subjects who do not follow doctor's advice, do not take medicine as prescribed, or have incomplete data, which may affect the judgment of efficacy or safety;
- 18.Subjects with serious concomitant diseases that, in the judgment of the investigator, endanger the subject's safety or affect the subject's completion of the study;
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
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
Xiaofeng Chen Feng Xiaofeng Chen, Chief physician, 86+13585172066, xiaofengch198019@126.com
Yongqian Gu Yongqian Yongqian Gu, Chief physician
About this study
Official title: Mecapegfilgrastim Combined With Adebrelimab and Chemotherapy as Neoadjuvant Therapy in Resectable GC/GEJC: A Prospective, Randomized, Multicenter, Phase 2 Study.
This study is a prospective, randomized ，multicencter, phase II clinical trial that aims to enroll patients with locally advanced gastric adenocarcinoma who have not received any prior treatment and are candidates for surgery. The purpose of this study is to assess the safety and efficacy of Mecapegfilgrastim Combined With Adebrelimab and 5- fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT)） as Neoadjuvant Therapy in Resectable gastric and gastroesophageal junction cancer
Read the detailed description
After being informed about the study and potential risks, patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomly divided into trial group A and trial group B: Trial group A receive the combination therapy of Mecapegfilgrastim combined with Adebrelimab and FLOT, and trial group B receive the combination therapy of Adebrelimab combined with FLOT, two weeks a cycle, surgery was performed after 4 cycles.
- Conditions
- GC/GEJC
- Being tested
- Mecapegfilgrastim, Adebrelimab, Docetaxel, Oxaliplatin, 5-Fluorouracil (5-FU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MecapegfilgrastimDrug
6 mg,HD d3,every 2weeks (Q2W)
AdebrelimabDrug
Adebrelimab：1200 mg，iv d1，every2 weeks (Q2W)
DocetaxelDrug
Docetaxel：50 mg/m2 iv gtt d1，every 2 weeks (Q2W)
OxaliplatinDrug
Oxaliplatin ：85 mg/m2 iv gtt d1，every2 weeks (Q2W)
5-Fluorouracil (5-FU)Drug
5-FU ：2600 mg/m2 ，intravenous infusion， 24h ，d1，every 2 weeks (Q2W)
Leucovorin (LV)Drug
LV：200 mg/m2 iv gtt d1，every 2 weeks (Q2W)
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Mecapegfilgrastim plus Adebrelimab and FLOT | Experimental | Mecapegfilgrastim：（6 mg, HD, d3） Adebrelimab （1200 mg，iv d1） Docetaxel（50 mg/m2 iv gtt d1） Oxaliplatin （85 mg/m2 iv gtt d1） 5- fluorouracil, leucovorin （200 mg/m2 iv gtt d1） for 4 cycles (every 2 weeks) before surgery. Receives: Drug: Mecapegfilgrastim; Drug: Adebrelimab; Drug: Docetaxel; Drug: Oxaliplatin; Drug: 5-Fluorouracil (5-FU); Drug: Leucovorin (LV) |
| Arm B: Adebrelimab plus FLOT | Experimental | Adebrelimab （1200 mg，iv d1） Docetaxel（50 mg/m2 iv gtt d1） Oxaliplatin （85 mg/m2 iv gtt d1） 5- fluorouracil, leucovorin （200 mg/m2 iv gtt d1） for 4 cycles (every 2 weeks) before surgery. Receives: Drug: Adebrelimab; Drug: Docetaxel; Drug: Oxaliplatin; Drug: 5-Fluorouracil (5-FU); Drug: Leucovorin (LV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR)
The pCR refers to the proportion of subjects with no residual tumor cells in the primary lesion based on Becker Grade 1a.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (5)
Major Pathological Response (MPR)
The proportion of subjects with resectable gastric cancer after neoadjuvant therapy who have less than 10% residual tumor cells in the primary lesion.
Measured: From enrollment to the end of treatment at 12weeks
R0 Resection Rate
The R0 resection rate refers to the proportion of subjects with resectable gastric cancer who complete R0 resection in the total number of subjects operated. R0 resection refers to microscopically negative margins.
Measured: From enrollment to the end of treatment at about 12 weeks
Event-free Survival (EFS)
The EFS refers to the time from the date of the random enrollment to disease progression, recurrence, or death (whichever occurs first).
Measured: 24 months
Overall Survival (OS)
The OS refers to the time from the date of the random enrollment to death from any cause. For subjects who are still alive at the time of the last follow-up, OS is censored at the time of the last follow-up. For subjects lost to follow-up, their OS is censored at the last confirmed alive time before loss to follow-up. The censored OS is defined as the time from the date of the first dose to the time of censoring.
Measured: 36 months
Chemotherapy completion rate
The proportion of patients who completed 4 cycles of FLOT chemotherapy in the total number of enrolled patients
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start30 Nov 2024 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GC/GEJCStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional Study Model.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684158
- Sponsor's protocol ID
- MA-GC-II-O17
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mecapegfilgrastim Combined With Adebrelimab and Chemotherapy as Neoadjuvant Therapy in Resectable GC/GEJC: A Prospective, Randomized, Multicenter, Phase 2 Study.
- ClinicalTrials.gov ID
- NCT06684158
- Acronym / sponsor ID
- MA-GC-II-O17
- Conditions
- GC/GEJC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 12 Nov 2024 (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 is a prospective, randomized ，multicencter, phase II clinical trial that aims to enroll patients with locally advanced gastric adenocarcinoma who have not received any prior treatment and are candidates for surgery. The purpose of this study is to assess the safety and efficacy of Mecapegfilgrastim Combined With Adebrelimab and 5- fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT)） as Neoadjuvant Therapy in Resectable gastric and gastroesophageal junction cancer
Detailed description
After being informed about the study and potential risks, patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomly divided into trial group A and trial group B: Trial group A receive the combination therapy of Mecapegfilgrastim combined with Adebrelimab and FLOT, and trial group B receive the combination therapy of Adebrelimab combined with FLOT, two weeks a cycle, surgery was performed after 4 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional Study Model.
| Arm | Type | Receives |
|---|---|---|
| Arm A: Mecapegfilgrastim plus Adebrelimab and FLOT | Experimental | Drug: Mecapegfilgrastim, Drug: Adebrelimab, Drug: Docetaxel, Drug: Oxaliplatin, Drug: 5-Fluorouracil (5-FU), Drug: Leucovorin (LV)Mecapegfilgrastim：（6 mg, HD, d3） Adebrelimab （1200 mg，iv d1） Docetaxel（50 mg/m2 iv gtt d1） Oxaliplatin （85 mg/m2 iv gtt d1） 5- fluorouracil, leucovorin （200 mg/m2 iv gtt d1） for 4 cycles (every 2 weeks) before surgery. |
| Arm B: Adebrelimab plus FLOT | Experimental | Drug: Adebrelimab, Drug: Docetaxel, Drug: Oxaliplatin, Drug: 5-Fluorouracil (5-FU), Drug: Leucovorin (LV)Adebrelimab （1200 mg，iv d1） Docetaxel（50 mg/m2 iv gtt d1） Oxaliplatin （85 mg/m2 iv gtt d1） 5- fluorouracil, leucovorin （200 mg/m2 iv gtt d1） for 4 cycles (every 2 weeks) before surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1.Subjects aged 18-75 years (including 18 and 75 years old);
- 2.Subjects who understand the study procedures and content, and voluntarily sign the written informed consent form;
- 3.Subjects with HER2-negative or HER2 status unknown gastric or gastroesophageal junction adenocarcinoma, clinically staged as T3-4a/N+M0 locally advanced gastric cancer by ultrasound gastroscopy, CT/MRI and other imaging evaluations.
- 4.Subjects who have not received prior systemic therapy.
- 5.Subjects with Eastern Cooperative Oncology Group Performance Status score (ECOG PS score): 0-1;
Key exclusion criteria (18 listed)
- 1.Subjects with a history of or concurrent with other tumors malignant, except for cured early-stage tumors, including basal cell carcinoma of the skin and carcinoma in situ of the cervix, and early-stage tumors such as stage I lung cancer and stage I rectal cancer that have received radical treatment and are judged by the investigator not to affect the subject's life in the short term.
- 2.Subjects who have participated in other drug clinical studies within 4 weeks;
- 3.Subjects with a history of haemorrhage, the severity of any grade ≥ 3 haemorrhage event according to CTCAE 5.0 criteria within 4 weeks prior to screening;
- 4.Prior to screening, there were known highly suspected distant metastases, such as suspected peritoneal nodules, suspected cancerous ascites, and no laparoscopic confirmation;
- 5.Subjects with hypertension that cannot be well controlled with single-drug therapy (blood pressure systolic > 140 mmHg, blood pressure diastolic > 90 mmHg); subjects with a history of unstable angina pectoris; subjects newly diagnosed with angina pectoris within 3 months before screening or with myocardial infarction within 6 months before screening; arrhythmia (including QTcF: male ≥ 450 ms, female ≥ 470 ms) requiring long-term use of antiarrhythmic drugs and New York Heart Association class ≥ II cardiac insufficiency;
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 |
|---|---|---|
| Mecapegfilgrastim6 mg,HD d3,every 2weeks (Q2W) | Drug | Arm A: Mecapegfilgrastim plus Adebrelimab and FLOT |
| AdebrelimabAdebrelimab：1200 mg，iv d1，every2 weeks (Q2W) | Drug | Arm A: Mecapegfilgrastim plus Adebrelimab and FLOT, Arm B: Adebrelimab plus FLOT |
| DocetaxelDocetaxel：50 mg/m2 iv gtt d1，every 2 weeks (Q2W) | Drug | Arm A: Mecapegfilgrastim plus Adebrelimab and FLOT, Arm B: Adebrelimab plus FLOT |
| OxaliplatinOxaliplatin ：85 mg/m2 iv gtt d1，every2 weeks (Q2W) | Drug | Arm A: Mecapegfilgrastim plus Adebrelimab and FLOT, Arm B: Adebrelimab plus FLOT |
| 5-Fluorouracil (5-FU)5-FU ：2600 mg/m2 ，intravenous infusion， 24h ，d1，every 2 weeks (Q2W) | Drug | Arm A: Mecapegfilgrastim plus Adebrelimab and FLOT, Arm B: Adebrelimab plus FLOT |
| Leucovorin (LV)LV：200 mg/m2 iv gtt d1，every 2 weeks (Q2W) | Drug | Arm A: Mecapegfilgrastim plus Adebrelimab and FLOT, Arm B: Adebrelimab plus FLOT |
Primary outcome
Pathologic Complete Response (pCR)
Time frame: From enrollment to the end of treatment at 12 weeks
The pCR refers to the proportion of subjects with no residual tumor cells in the primary lesion based on Becker Grade 1a.
5 secondary outcomes
Major Pathological Response (MPR)
Time frame: From enrollment to the end of treatment at 12weeks
R0 Resection Rate
Time frame: From enrollment to the end of treatment at about 12 weeks
Event-free Survival (EFS)
Time frame: 24 months
Overall Survival (OS)
Time frame: 36 months
Chemotherapy completion rate
Time frame: 8 weeks
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 12 Nov 2024.
- 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.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
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 Mecapegfilgrastim, Adebrelimab and Docetaxel in people with GC/GEJC, run by The First Affiliated Hospital with Nanjing Medical 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 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: opening soon, as of the sponsor's last update on 12 Nov 2024. 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?
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?
Pathologic Complete Response (pCR) (time frame: From enrollment to the end of treatment at 12 weeks). 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 12 Nov 2024.