Gastric CancerEASOBFGENCT06603974
The Efficacy and Safety of Benmelstobart for GC/EGC
A study testing surgery, Benmelstobart and tegafur in people with Gastric Cancer, run by Xijing Hospital.
Trial summary
The goal of this clinical trial is to evaluate the major pathological response (MPR) rate of locally advanced gastric cancer / gastroesophageal junction cancer treated with bemosumab combined with antiangiogenic drugs and neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- surgery, Benmelstobart and tegafur
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 16 Oct 2024to 26 Dec 2026
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.18 ≤ 70 years old, male or female;
- 2. ECoG score 0-1;
- 3. patients with locally advanced gastric cancer / gastroesophageal junction cancer confirmed by pathology (histology or cytology) (according to the WHO classification in 2015);
- 4. according to the eighth edition of clinical tumor TNM staging, patients with t3~4n+m0 gastric cancer / gastroesophageal junction cancer confirmed to be resectable or potentially resectable by endoscopic ultrasound and enhanced CT;
- 5. have measurable lesions (according to RECIST 1.1 standard, the long diameter of CT scan of tumor lesions is ≥ 10mm, and the short diameter of CT scan of lymph node lesions is ≥ 15mm;), and the tumor is \> 2cm directly;
- 6. patients who were initially diagnosed with gastric cancer / gastroesophageal junction cancer without radiotherapy, chemotherapy, surgery and targeted therapy before enrollment;
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- 7. if the main organ function is normal, it meets the following criteria:
- Blood routine examination must meet the following requirements (no blood transfusion, no use of hematopoietic factors and no use of drugs for correction within 14 days):
- ANC ≥ 1.5 × 109/l;
- PLT ≥ 100 × 109/l;
- HB ≥ 90 g/L；
- Biochemical tests must meet the following criteria:
- TBIL ≤ 1.5 × ULN;
- Alt, AST ≤ 2.5 × ULN
- Serum creatinine SCR ≤ 1.5 × ULN, endogenous creatinine clearance ≥ 50 ml / min (Cockcroft Gault formula);
- Coagulation function must meet: INR ≤ 1.5 × ULN and APTT ≤ 1.5 × ULN;
- 8. patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥ 450ms (male), QTc ≥ 470ms (female)) and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification);
- 9. female subjects of childbearing age must have a serum pregnancy test within 3 days before starting the study medication, and the result is negative, and are willing to use a medically approved high-efficiency contraceptive measure (such as IUD, contraceptive or condom) during the study period and within 3 months after the last administration of study medication; For male subjects whose partner is a female of childbearing age, they should be surgically sterilized, or agree to use effective methods of contraception during the study and within 3 months after the last study administration; The subjects voluntarily joined the study and signed the informed consent form. -10.The compliance was good and they cooperated with the follow-up;
Who cannot join
- 1. exclusion criteria of target disease
- Patients with distant metastasis;
- Subjects who had previously received anti-PD-1 (L1) or CTLA4 mAb therapy;
- 2. medical history and comorbidities
- Other malignant tumors in the past 3 years;
- Have any history of active autoimmune disease or autoimmune disease (as follows, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); Patients with vitiligo or childhood asthma have been completely relieved and can be included without any intervention in adults; Patients who needed bronchodilators for medical intervention could not be included;
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- Immunosuppressive drugs used within 14 days before the first use of study drugs, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e. no more than 10 mg/ day prednisone or its equivalent);
- Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg despite optimal medical treatment);
- Patients with newly diagnosed angina within 3 months before screening or myocardial infarction within 6 months before screening; Arrhythmias (including QTCF: ≥ 450 ms for men and ≥ 470 MS for women) require long-term use of antiarrhythmic drugs and New York Heart Association class ≥ II cardiac insufficiency; Or uncontrollable heart failure;
- There is evidence that there are previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and severe impairment of lung function;
- Complicated with severe infection within 4 weeks before the first administration (such as requiring intravenous infusion of antibiotics, antifungal or antiviral drugs), or fever of unknown cause \>38.5 ° C during the screening period / before the first administration;
- Clinically significant hemoptysis (more than 50 ml hemoptysis per day) within 3 months before the study, or clinically significant bleeding symptoms or obvious bleeding tendency (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood + + or above the baseline, or suffering from vasculitis, etc.).
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Live attenuated vaccine was administered within 4 weeks before the first dose or planned during the study;
- 3. physical examination and laboratory examination
- Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 iu/ml), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analysis method), or combined hepatitis B and C co infection;
- Pregnant or lactating women; Patients with fertility are unwilling or unable to take effective contraceptive measures;
- Known to have a positive history of human immunodeficiency virus (HIV) examination or known to have acquired immune deficiency syndrome (AIDS);
- 4. allergy, anaphylaxis and adverse drug reactions
- Severe allergic reaction to other monoclonal antibodies;
- Allergy or intolerance to infusion;
- Have a history of severe allergy to antiangiogenic drugs or their preventive drugs;
- 5. subjects who are participating in other clinical studies or whose first medication time is less than 4 weeks from the end of the previous clinical study (the last medication), or who have 5 half lives of the study drug;
- 6. the subject is known to have a history of psychotropic substance abuse, alcohol abuse or drug abuse;
- 7. the investigator believes that there are any conditions that may damage the subject or cause the subject to be unable to meet or perform the research requirements.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory Study of Benmelstobart in Combination with Antiangiogenesis Drugs and Neoadjuvant Chemotherapy for Locally Progressive Gastric Cancer / Gastroesophageal Junction Carcinoma
The goal of this clinical trial is to evaluate the major pathological response (MPR) rate of locally advanced gastric cancer / gastroesophageal junction cancer treated with bemosumab combined with antiangiogenic drugs and neoadjuvant chemotherapy.
Researchers will use drug Benmelstobart in combination with antiangiogenesis drugs and newadjuvant chemotherapy to see if the drug works to treat locally advanced gastric cancer / gastroesophageal junction cancer.
Participants will:injection drug Benmelstobart，On the first day of each cycle, 3 weeks (21 days) were a treatment cycle.
Read the detailed description
The phase i/ii clinical study of benmelstobart combined with anlotinib, oxaliplatin and capecitabine in the first-line treatment of gastric / gastroesophageal junction adenocarcinoma has shown good efficacy and safety. Anti vascular drugs have also shown excellent anti-tumor effects in the neoadjuvant treatment of locally advanced gastric cancer. Therefore, this study plans to explore the efficacy of benmelstobart combined with anti angiogenic drugs and neoadjuvant chemotherapy for locally advanced gastric cancer / gastroesophageal junction cancer, and make up for this part of the treatment gap.
- Conditions
- Gastric Cancer
- Being tested
- surgery, Benmelstobart, tegafur, oxaliplatin, albumin paclitaxel
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
After receiving the corresponding neoadjuvant treatment for 2 cycles, surgery was performed within 3-6 weeks after drug withdrawal.
BenmelstobartDrug
1200mg, diluted to 250ml with normal saline, infusion time 60 ± 10mins. The first day of each cycle, 3 weeks (21 days) as a treatment cycle
tegafurDrug
it needs to be administered according to the patient\'s body surface area\< 40mg / time at 1.25m2; \> 50mg/ time for 1.25m2 and \<1.5m2; \> 60mg/ time at 1.5m2; Oral, twice a day, after morning and evening meals, for 14 consecutive days, rest for 7 days, as a treatment cycle; Repeat every 3 weeks;
oxaliplatinDrug
130mg/m2, administered on the first day of each cycle, repeated every 3 weeks;
albumin paclitaxelDrug
260mg/m2, intravenous infusion, 30 minutes per infusion, once every 3 weeks, administered on the first and eighth days of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Benmelstobart combined with antiangiogenic drugs and neoadjuvant chemotherapy | Experimental | Benmelstobart: 1200mg, diluted to 250ml with normal saline, infusion time 60 ± 10mins. The first day of each cycle, 3 weeks (21 days) as a treatment cycle; antiangiogenic drugs are decided by the investigator according to the actual situation; tegafur: it needs to be administered according to the patient's body surface area< 40mg / time at 1.25m2; > 50mg/ time for 1.25m2 and <1.5m2; > 60mg/ time at 1.5m2; Oral, twice a day, after morning and evening meals, for 14 consecutive days, rest for 7 days, as a treatment cycle; Repeat every 3 weeks; oxaliplatin: 130mg/m2, administered on the first day of each cycle, repeated every 3 weeks; Chemotherapy drugs can also be selected by the investigator.
albumin paclitaxel: 260mg/m2, intravenous infusion, 30 minutes per infusion, once every 3 weeks, administered on the first and eighth days of each cycle Receives: Procedure: surgery; Drug: Benmelstobart; Drug: tegafur; Drug: oxaliplatin; Drug: albumin paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response
Tumor tissue samples surgically removed after neoadjuvant therapy, without residual tumor cells
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Oct 2024 (estimated)
- Primary completion26 Jul 2026 (estimated)
- Study completion26 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Xijing 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liu Hong, master, Study chair, Department of Digestive Surgery, Xijing Hospital, Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603974
- Sponsor's protocol ID
- TQXB-GC-001
- Acronym
- EASOBFGE
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Benmelstobart in Combination with Antiangiogenesis Drugs and Neoadjuvant Chemotherapy for Locally Progressive Gastric Cancer / Gastroesophageal Junction Carcinoma
- ClinicalTrials.gov ID
- NCT06603974
- Acronym / sponsor ID
- EASOBFGE / TQXB-GC-001
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 16 Oct 2024 (estimated)
- Primary completion
- 26 Jul 2026 (estimated)
- Study completion
- 26 Dec 2026 (estimated)
- First posted
- 19 Sep 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.
The goal of this clinical trial is to evaluate the major pathological response (MPR) rate of locally advanced gastric cancer / gastroesophageal junction cancer treated with bemosumab combined with antiangiogenic drugs and neoadjuvant chemotherapy.
Researchers will use drug Benmelstobart in combination with antiangiogenesis drugs and newadjuvant chemotherapy to see if the drug works to treat locally advanced gastric cancer / gastroesophageal junction cancer.
Participants will:injection drug Benmelstobart，On the first day of each cycle, 3 weeks (21 days) were a treatment cycle.
Detailed description
The phase i/ii clinical study of benmelstobart combined with anlotinib, oxaliplatin and capecitabine in the first-line treatment of gastric / gastroesophageal junction adenocarcinoma has shown good efficacy and safety. Anti vascular drugs have also shown excellent anti-tumor effects in the neoadjuvant treatment of locally advanced gastric cancer. Therefore, this study plans to explore the efficacy of benmelstobart combined with anti angiogenic drugs and neoadjuvant chemotherapy for locally advanced gastric cancer / gastroesophageal junction cancer, and make up for this part of the treatment gap.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benmelstobart combined with antiangiogenic drugs and neoadjuvant chemotherapy | Experimental | Procedure: surgery, Drug: Benmelstobart, Drug: tegafur, Drug: oxaliplatin, Drug: albumin paclitaxelBenmelstobart: 1200mg, diluted to 250ml with normal saline, infusion time 60 ± 10mins. The first day of each cycle, 3 weeks (21 days) as a treatment cycle; antiangiogenic drugs are decided by the investigator according to the actual situation; tegafur: it needs to be administered according to the patient's body surface area< 40mg / time at 1.25m2; > 50mg/ time for 1.25m2 and <1.5m2; > 60mg/ time at 1.5m2; Oral, twice a day, after morning and evening meals, for 14 consecutive days, rest for 7 days, as a treatment cycle; Repeat every 3 weeks; oxaliplatin: 130mg/m2, administered on the first day of each cycle, repeated every 3 weeks; Chemotherapy drugs can also be selected by the investigator. albumin paclitaxel: 260mg/m2, intravenous infusion, 30 minutes per infusion, once every 3 weeks, administered on the first and eighth days of each cycle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 1.18 ≤ 70 years old, male or female;
- 2. ECoG score 0-1;
- 3. patients with locally advanced gastric cancer / gastroesophageal junction cancer confirmed by pathology (histology or cytology) (according to the WHO classification in 2015);
- 4. according to the eighth edition of clinical tumor TNM staging, patients with t3~4n+m0 gastric cancer / gastroesophageal junction cancer confirmed to be resectable or potentially resectable by endoscopic ultrasound and enhanced CT;
- 5. have measurable lesions (according to RECIST 1.1 standard, the long diameter of CT scan of tumor lesions is ≥ 10mm, and the short diameter of CT scan of lymph node lesions is ≥ 15mm;), and the tumor is \&gt; 2cm directly;
Key exclusion criteria (25 listed)
- 1. exclusion criteria of target disease
- 2. medical history and comorbidities
- 3. physical examination and laboratory examination
- 4. allergy, anaphylaxis and adverse drug reactions
- 5. subjects who are participating in other clinical studies or whose first medication time is less than 4 weeks from the end of the previous clinical study (the last medication), or who have 5 half lives of the study drug;
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 |
|---|---|---|
| surgeryAfter receiving the corresponding neoadjuvant treatment for 2 cycles, surgery was performed within 3-6 weeks after drug withdrawal. | Procedure or surgery | Benmelstobart combined with antiangiogenic drugs and neoadjuvant chemotherapy |
| Benmelstobart1200mg, diluted to 250ml with normal saline, infusion time 60 ± 10mins. The first day of each cycle, 3 weeks (21 days) as a treatment cycle | Drug | Benmelstobart combined with antiangiogenic drugs and neoadjuvant chemotherapy |
| tegafurit needs to be administered according to the patient\'s body surface area\< 40mg / time at 1.25m2; \> 50mg/ time for 1.25m2 and \<1.5m2; \> 60mg/ time at 1.5m2; Oral, twice a day, after morning and evening meals, for 14 consecutive days, rest for 7 days, as a treatment cycle; Repeat every 3 weeks; | Drug | Benmelstobart combined with antiangiogenic drugs and neoadjuvant chemotherapy |
| oxaliplatin130mg/m2, administered on the first day of each cycle, repeated every 3 weeks; | Drug | Benmelstobart combined with antiangiogenic drugs and neoadjuvant chemotherapy |
| albumin paclitaxel260mg/m2, intravenous infusion, 30 minutes per infusion, once every 3 weeks, administered on the first and eighth days of each cycle | Drug | Benmelstobart combined with antiangiogenic drugs and neoadjuvant chemotherapy |
Primary outcome
Pathological complete response
Time frame: 2 years
Tumor tissue samples surgically removed after neoadjuvant therapy, without residual tumor cells
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 19 Sep 2024.
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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.
Liu Hong, master study chair
Department of Digestive Surgery, Xijing Hospital, Air Force Medical University
Questions about this trial
What is this clinical trial studying?
A study testing surgery, Benmelstobart and tegafur in people with Gastric Cancer, run by Xijing Hospital.
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 25 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 19 Sep 2024. 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.
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 Liu Hong, master (18792807591 ext. 0086, 18792804403@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (time frame: 2 years). 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 19 Sep 2024.