Adenocarcinoma of the Esophagogastric JunctionPhase 2NCT06681298
A Multi-center, Two-arm, Phase 2 Clinical Study on the Perioperative Treatment of HER2-positive Resectable Esophagogastric Junctional Adenocarcinoma With Nabulimab Combined With FLOT and Trastuzumab VS FLOT Combined With Trastuzumab
A Phase 2 study testing The experimental group received Nivolumab in people with Adenocarcinoma of the Esophagogastric Junction and Perioperative Period, run by xiaohua li at 1 site in China.
Trial summary
Patients with Her2+ resectable gastroesophageal conjunctive adenocarcinoma were randomly divided into observation group and control group. The observation group received preoperative nabuliumab combined with FLOT and trastuzumab + surgical treatment + postoperative nabuliumab combined with FLOT and trastuzumab. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adenocarcinoma of the Esophagogastric Junction, Perioperative Period
- What is being tested?
- The experimental group received Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 1 May 2029
- 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
- Age 18-75 years old;
- esophagogastric junction adenocarcinoma (including Siewert type I, Siewert type II, and Siewert type III) with histopathologic or cytological confirmation of HER2-positive (defined as positive immunohistochemical [IHC] greater than or equal to 2+ and fluorescence in situ hybridization [FISH]);
- The cTNM stages were cT3-4a, N+, M0 according to endoscopic ultrasound or enhanced CT/MRI scanning (combined with ultrasonic gastroscopy and diagnostic laparoscopic exploration if necessary) (refer to the 8th edition AJCCTNM staging system), and the lesions were resected as assessed by the investigator;
- Expected survival time > 6 months;
- ECOG PS score 0 or 1;
- PD-L1 does not require;
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- No prior treatment;
- Hematological indexes were basically normal: white blood cell count ≥4×109/L; Absolute neutrophil count ≥1.5×109/L; Platelet ≥100×109/L; Hemoglobin ≥ 90 g/Lg/L;
- Basically normal renal function: serum creatinine ≤1.5×ULN or creatinine clearance (CrCl)>60 mL/min(using the Cockcroft-Gault formula);
- Basically normal liver function: serum total bilirubin ≤1.5×ULN; Aspartate aminotransferase (AST) ≤2.5×ULN; Alanine aminotransferase (ALT) ≤2.5×ULN;
- Female patients must have a negative urine pregnancy test before the start of the study (not applicable to patients with bilateral oophorectomy and/or hysterectomy or postmenopausal patients)
- Sign written informed consent.
Who cannot join
- (1) No efficacy and/or safety evaluation has been performed; (2) The investigator believes that the patient is not suitable to continue (reasons for withdrawal should be recorded) (3) The patient requested that the trial be terminated; (4) Serious violation of protocol: participating in this study while using other anti-tumor drugs and/or modern Chinese medicine preparations with anti-cancer indications.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of the Air Force Medical University
Xi'an, Shaanxi, 710032
About this study
Patients with Her2+ resectable gastroesophageal conjunctive adenocarcinoma were randomly divided into observation group and control group. The observation group received preoperative nabuliumab combined with FLOT and trastuzumab + surgical treatment + postoperative nabuliumab combined with FLOT and trastuzumab. The control group was treated with preoperative FLOT combined with trastuzumab + surgical treatment + postoperative FLOT combined with trastuzumab. 4 cycles were performed before and after surgery in both groups, with one cycle every 2 weeks. The specific administration was docetaxel 50mg/m2 iv,d1, oxaliplatin 85mg/m2 iv,d1, calcium leucovorin 200mg/m2 iv,d1,5-FU 2600mg/m2 iv,d1, infusion 24h; Nebulizumab 240mg iv,d2, 30 minutes per intravenous infusion, trastuzumab 4mg/kg iv,d2 (load dose 6mg /kg). Surgical treatment was evaluated by the investigator within 3-4 weeks after the last dosing. After 4 cycles of adjuvant therapy, the observation group received nebuliumab combined with trastuzumab, while the control group received maintenance therapy with trastuzumab. Both groups received 10 cycles, one cycle every 2 weeks. The specific administration was as follows: nebuliuzumab 240mg iv,d1, 30 minutes per intravenous infusion; Trastuzumab 4mg/kg intravenously.
Read the detailed description
This is a prospective, multicenter, randomized controlled clinical study. A total of 36 patients with locally advanced esophagogastric conjoint adenocarcinoma without any treatment and resection were included in this study. After signing informed consent and meeting the screening criteria, a total of 36 patients were randomized into the observation group and the control group (18 cases and 18 cases, respectively) without blindness. Other participants include the Second Affiliated Hospital of Air Force Medical University, Henan Provincial People's Hospital, Cancer Hospital of Tianjin Medical University, Zhongshan Hospital Affiliated to Shanghai Fudan University, and the First Affiliated Hospital of Xi 'an Jiaotong University. The research groups were as follows: patients with resectable gastroesophageal conjunctive adenocarcinoma were randomly divided into observation group and control group. The observation group received preoperative nabuliumab combined with FLOT and trastuzumab + surgical treatment + postoperative nabuliumab combined with FLOT and trastuzumab. The control group was treated with preoperative FLOT combined with trastuzumab + surgical treatment + postoperative FLOT combined with trastuall Zumab. Preoperative and postoperative cycles were 4 in both groups, with one cycle every 2 weeks. Specific administration was as follows: Docetaxel 50mg/m2 iv,d1, oxaliplatin 85mg/m2 iv,d1, calcium leucovorin 200mg/m2 iv,d1,5-FU 2600mg/m2 iv,d1, infusion 24h; Nebulizumab 240mg iv,d2, 30 minutes per intravenous infusion, trastuzumab 4mg/kg iv,d2 (load dose 6mg /kg). At 3-4 weeks after the completion of the last dosing cycle, the efficacy of neoadjuvant therapy and the possibility of radical resection were evaluated in combination with preoperative imaging examination, and radical surgical treatment was performed. After the operation, the investigator will determine whether to carry out adjuvant treatment and choose the appropriate treatment plan (the first treatment should start from 3-6W after the operation and should not exceed 3 months). After 4 cycles of adjuvant therapy, the observation group was treated with nebuliumab combined with trastuzumab, and the control group was treated with trastuzumab maintenance therapy, with 10 cycles for each The specific administration was as follows: 240mg iv,d1, intravenous infusion for 30 minutes each time; Trastuzumab 4mg/kg intravenously. Resection of esophagogastric junction carcinoma was performed based on the 2023 Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and treatment of gastric cancer.
- Being tested
- The experimental group received Nivolumab
- Keywords
- Nivolumab, adenocarcinoma of the esophagogastric junction, FLOT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The experimental group received NivolumabDrug
Also called Trastuzumab, FLOT
Trastuzumab and the FLOT chemotherapy regimen are clearly recommended by guidelines, whereas Nivolumab is currently requiring further research validation.
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab group | Experimental | Preoperative nabuliumab combined with FLOT and trastuzumab + surgical treatment + postoperative nabuliumab combined with FLOT and trastuzumab. There were 4 cycles before and after surgery, one cycle every 2 weeks. The specific administration was: docetaxel 50mg/m2 iv,d1, oxaliplatin 85mg/m2 iv,d1, calcium leucovorin 200mg/m2 iv,d1,5-FU 2600mg/m2 iv,d1, infusion 24h; Nebulizumab 240mg iv,d2, 30 minutes per intravenous infusion, trastuzumab 4mg/kg iv,d2 (load dose 6mg /kg). Receives: Drug: The experimental group received Nivolumab |
| Control group | Active comparator | The control group was treated with preoperative FLOT combined with trastuzumab + surgical treatment + postoperative FLOT combined with trastuzumab. Preoperative and postoperative cycles were 4 in both groups, with one cycle every 2 weeks. Specific administration was as follows: Docetaxel 50mg/m2 iv,d1, oxaliplatin 85mg/m2 iv,d1, calcium leucovorin 200mg/m2 iv,d1,5-FU 2600mg/m2 iv,d1, infusion 24h; Trastuzumab 4mg/kg iv,d2 (load dose 6mg /kg). Receives: Drug: The experimental group received Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (pCR)
Pathological complete response rate refers to the proportion of primary tumor sites and surgical specimens with no viable tumor cells (ypT0N0) in all resected lymph nodes to the total number of patients evaluated centrally by the study pathologist
Measured: 30 days
Secondary outcomes (6)
Objective response rate (ORR)
Objective response rate (ORR) : ORR is the proportion of subjects who achieved partial and complete response on imaging assessment (RECIST v1.1) after the end of neoadjuvant therapy
Measured: 30 days
Progression-free survival (PFS)
Progression-free survival (PFS) : PFS is the time from the date of enrollment in the study to the date of death from all causes
Measured: 1,3,5 years
Overall survival (OS)
Overall survival (OS) : OS is the amount of time a patient can survive treatment without dying from any condition
Measured: 1,3,5 years
Major pathological response rate (MPR)
Major pathological response rate (MPR) : MPR refers to the proportion of patients with residual tumor cells < 10% after surgery to determine the pathological status of the primary lesion
Measured: 30 days
Duration of response (DOR)
Duration of response (DOR) : The DOR is the time from the first response until disease progression is first recorded or death occurs
Measured: 5 years
Adverse Event Rate (AE)
Adverse Event Rate (AE) : Any adverse events that may be related to the investigational drug that occur while receiving neoadjuvant therapy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 May 2024
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the Esophagogastric JunctionStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- xiaohua li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, xiaohua li, Xijing Hospital of Digestive Diseases
- Investigators
- Ruiqi Gao, Principal investigator, Department of Gastrointestinal Surgery, Xijing Hospital, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681298
- Sponsor's protocol ID
- KY20242180-C-1
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share in the form of an article or email
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Two-arm, Phase 2 Clinical Study on the Perioperative Treatment of HER2-positive Resectable Esophagogastric Junctional Adenocarcinoma With Nabulimab Combined With FLOT and Trastuzumab VS FLOT Combined With Trastuzumab
- ClinicalTrials.gov ID
- NCT06681298
- Acronym / sponsor ID
- KY20242180-C-1
- Keywords
- Nivolumab, adenocarcinoma of the esophagogastric junction, FLOT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- xiaohua liUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 8 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.
Patients with Her2+ resectable gastroesophageal conjunctive adenocarcinoma were randomly divided into observation group and control group. The observation group received preoperative nabuliumab combined with FLOT and trastuzumab + surgical treatment + postoperative nabuliumab combined with FLOT and trastuzumab. The control group was treated with preoperative FLOT combined with trastuzumab + surgical treatment + postoperative FLOT combined with trastuzumab. 4 cycles were performed before and after surgery in both groups, with one cycle every 2 weeks. The specific administration was docetaxel 50mg/m2 iv,d1, oxaliplatin 85mg/m2 iv,d1, calcium leucovorin 200mg/m2 iv,d1,5-FU 2600mg/m2 iv,d1, infusion 24h; Nebulizumab 240mg iv,d2, 30 minutes per intravenous infusion, trastuzumab 4mg/kg iv,d2 (load dose 6mg /kg). Surgical treatment was evaluated by the investigator within 3-4 weeks after the last dosing. After 4 cycles of adjuvant therapy, the observation group received nebuliumab combined with trastuzumab, while the control group received maintenance therapy with trastuzumab. Both groups received 10 cycles, one cycle every 2 weeks. The specific administration was as follows: nebuliuzumab 240mg iv,d1, 30 minutes per intravenous infusion; Trastuzumab 4mg/kg intravenously.
Detailed description
This is a prospective, multicenter, randomized controlled clinical study. A total of 36 patients with locally advanced esophagogastric conjoint adenocarcinoma without any treatment and resection were included in this study. After signing informed consent and meeting the screening criteria, a total of 36 patients were randomized into the observation group and the control group (18 cases and 18 cases, respectively) without blindness. Other participants include the Second Affiliated Hospital of Air Force Medical University, Henan Provincial People's Hospital, Cancer Hospital of Tianjin Medical University, Zhongshan Hospital Affiliated to Shanghai Fudan University, and the First Affiliated Hospital of Xi 'an Jiaotong University. The research groups were as follows: patients with resectable gastroesophageal conjunctive adenocarcinoma were randomly divided into observation group and control group. The observation group received preoperative nabuliumab combined with FLOT and trastuzumab + surgical treatment + postoperative nabuliumab combined with FLOT and trastuzumab. The control group was treated with preoperative FLOT combined with trastuzumab + surgical treatment + postoperative FLOT combined with trastuall Zumab. Preoperative and postoperative cycles were 4 in both groups, with one cycle every 2 weeks. Specific administration was as follows: Docetaxel 50mg/m2 iv,d1, oxaliplatin 85mg/m2 iv,d1, calcium leucovorin 200mg/m2 iv,d1,5-FU 2600mg/m2 iv,d1, infusion 24h; Nebulizumab 240mg iv,d2, 30 minutes per intravenous infusion, trastuzumab 4mg/kg iv,d2 (load dose 6mg /kg). At 3-4 weeks after the completion of the last dosing cycle, the efficacy of neoadjuvant therapy and the possibility of radical resection were evaluated in combination with preoperative imaging examination, and radical surgical treatment was performed. After the operation, the investigator will determine whether to carry out adjuvant treatment and choose the appropriate treatment plan (the first treatment should start from 3-6W after the operation and should not exceed 3 months). After 4 cycles of adjuvant therapy, the observation group was treated with nebuliumab combined with trastuzumab, and the control group was treated with trastuzumab maintenance therapy, with 10 cycles for each The specific administration was as follows: 240mg iv,d1, intravenous infusion for 30 minutes each time; Trastuzumab 4mg/kg intravenously. Resection of esophagogastric junction carcinoma was performed based on the 2023 Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and treatment of gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nivolumab group | Experimental | Drug: The experimental group received NivolumabPreoperative nabuliumab combined with FLOT and trastuzumab + surgical treatment + postoperative nabuliumab combined with FLOT and trastuzumab. There were 4 cycles before and after surgery, one cycle every 2 weeks. The specific administration was: docetaxel 50mg/m2 iv,d1, oxaliplatin 85mg/m2 iv,d1, calcium leucovorin 200mg/m2 iv,d1,5-FU 2600mg/m2 iv,d1, infusion 24h; Nebulizumab 240mg iv,d2, 30 minutes per intravenous infusion, trastuzumab 4mg/kg iv,d2 (load dose 6mg /kg). |
| Control group | Active comparator | Drug: The experimental group received NivolumabThe control group was treated with preoperative FLOT combined with trastuzumab + surgical treatment + postoperative FLOT combined with trastuzumab. Preoperative and postoperative cycles were 4 in both groups, with one cycle every 2 weeks. Specific administration was as follows: Docetaxel 50mg/m2 iv,d1, oxaliplatin 85mg/m2 iv,d1, calcium leucovorin 200mg/m2 iv,d1,5-FU 2600mg/m2 iv,d1, infusion 24h; Trastuzumab 4mg/kg iv,d2 (load dose 6mg /kg). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-75 years old;
- esophagogastric junction adenocarcinoma (including Siewert type I, Siewert type II, and Siewert type III) with histopathologic or cytological confirmation of HER2-positive (defined as positive immunohistochemical [IHC] greater than or equal to 2+ and fluorescence in situ hybridization [FISH]);
- The cTNM stages were cT3-4a, N+, M0 according to endoscopic ultrasound or enhanced CT/MRI scanning (combined with ultrasonic gastroscopy and diagnostic laparoscopic exploration if necessary) (refer to the 8th edition AJCCTNM staging system), and the lesions were resected as assessed by the investigator;
- Expected survival time > 6 months;
- ECOG PS score 0 or 1;
Key exclusion criteria (1 listed)
- (1) No efficacy and/or safety evaluation has been performed; (2) The investigator believes that the patient is not suitable to continue (reasons for withdrawal should be recorded) (3) The patient requested that the trial be terminated; (4) Serious violation of protocol: participating in this study while using other anti-tumor drugs and/or modern Chinese medicine preparations with anti-cancer indications.
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 |
|---|---|---|
| The experimental group received NivolumabAlso: Trastuzumab, FLOTTrastuzumab and the FLOT chemotherapy regimen are clearly recommended by guidelines, whereas Nivolumab is currently requiring further research validation. | Drug | Control group, Nivolumab group |
Primary outcome
Pathological complete response rate (pCR)
Time frame: 30 days
Pathological complete response rate refers to the proportion of primary tumor sites and surgical specimens with no viable tumor cells (ypT0N0) in all resected lymph nodes to the total number of patients evaluated centrally by the study pathologist
6 secondary outcomes
Objective response rate (ORR)
Time frame: 30 days
Progression-free survival (PFS)
Time frame: 1,3,5 years
Overall survival (OS)
Time frame: 1,3,5 years
Major pathological response rate (MPR)
Time frame: 30 days
Duration of response (DOR)
Time frame: 5 years
Adverse Event Rate (AE)
Time frame: 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 8 Nov 2024.
- Individual participant dataSharing planned: Yes. Share in the form of an article or email
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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.
Ruiqi Gao principal investigator
Department of Gastrointestinal Surgery, Xijing Hospital, Fourth Military Medical University
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 The experimental group received Nivolumab in people with Adenocarcinoma of the Esophagogastric Junction and Perioperative Period, run by xiaohua li 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 12 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 8 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (pCR) (time frame: 30 days). 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 8 Nov 2024.