Gastroesophageal Junction AdenocarcinomaPhase 2NCT03368131
Concurrent Neoadjuvant Chemoradiotherapy Plus Trastuzumab in the Treatment of Siewert II ，III of Human Epidermal Growth Factor Receptor-2(HER-2) Positive Gastroesophageal Junction Adenocarcinoma： A Randomized, Controlled Clinical Study
A Phase 2 study testing Trastuzumab, Capecitabine and Oxaliplatin in people with Gastroesophageal Junction Adenocarcinoma, run by Hebei Medical University at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of patients who receive concurrent neoadjuvant chemoradiotherapy for Siewert II ，III of locally advanced HER-2 Positive adenocarcinoma at gastroesophageal junction Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Trastuzumab, Capecitabine and Oxaliplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 31 Dec 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age:18 to 60 years old (man or female);
- confirmed to Siewert II , III of locally advanced adenocarcinoma at gastroesophageal junction. The her-2 positive was detected by immunohistochemistry or Fluorescence in SituHybridization(FISH);
- Patients with Stage for Ⅲ by Endorectal Ultrasonography( EUS), Computed Tomography(CT) (or Positron Emission Tomography(PET )-CT) and laparoscopic (According to the eighth edition of American Joint Committee on Cancer (AJCC) );
- Patients are diagnosed as potentially resectable by multidisciplinary team, no surgical contraindications, and expected to be surgical resection;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Major organ function has to meet the following criteria:
Show all 9Show fewer
- HB≥80g/L; ANC≥1.5×109/L; PLT≥90×109/L; Alanine Transaminase (ALT) and Aspartate Transaminase(AST)≤2.5×ULN, but<≤5×ULN if the transferase elevation is due to liver metastases； Total Bilirubin(TBIL)<1.5×ULN； Serum creatinine ≤1.5×ULN;Serum albumin ≥ 30g / L
- Life expectancy greater than or equal to 6 months;
- Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Who cannot join
- Allergic to trastuzumab, capecitabine and oxaliplatin;
- severe diseases such as liver and kidney，myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia，which affect the situation of chemotherapy or surgery
- A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc);
- Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +); Has melena and hematemesis in two months;
- Coagulant function abnormality (International Normalized Ratio(INR) > 1.5 ULN, Activated Partial Thromboplastin Time(APTT ) > 1.5 ULN), with bleeding tendency;
- Pregnant or lactating women;
Show all 10Show fewer
- Patients with other malignant tumors within 5 years (except for curable skin basal cell carcinoma and cervical carcinoma in situ);
- History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- Less than 4 weeks from the last clinical trial;
- The researchers think inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site
Fourth Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
About this study
Official title: A Prospective Study of Concurrent Neoadjuvant Chemoradiotherapy Plus Trastuzumab for Siewert II ，III of HER-2 Positive Adenocarcinoma at Gastroesophageal Junction
The purpose of this study is to assess the efficacy and safety of patients who receive concurrent neoadjuvant chemoradiotherapy for Siewert II ，III of locally advanced HER-2 Positive adenocarcinoma at gastroesophageal junction
- Conditions
- Gastroesophageal Junction Adenocarcinoma
- Being tested
- Trastuzumab, Capecitabine, Oxaliplatin, Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
intravenously administered with the loading dose of 8 mg/kg followed by maintenance dose of 6mg/kg in day 1 of each cycle
CapecitabineDrug
825~1000mg/m2 bid d1-14
OxaliplatinDrug
130 mg/m2 Ivgtt d1 q3w
RadiotherapyRadiation
45 Gray (unit) Gy/25f （1.8Gy/f/d，5 f/w）
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab XELOX and radiotherapy | Experimental | Trastuzumab is intravenously administered with the loading dose of 8 mg/kg followed by maintenance dose of 6mg/kg in day 1 of each cycle. XELOX：Capecitabine 825~1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy：45 Gray (unit)Gy/25f （1.8Gy/f/d，5 f/w） Receives: Drug: Trastuzumab; Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Radiotherapy |
| XELOX and radiotherapy | Active comparator | Capecitabine：825~1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy：45Gy/25f （1.8Gy/f/d，5 f/w） Receives: Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pathological complete response rate(pCR)
The lesion disappeared completely by pathology
Measured: within 3 weeks after surgery
Secondary outcomes (6)
Overall survival (OS)
Baseline to measured date of death from any cause
Measured: 3 years
Disease-free survival(DFS)
Baseline to measured date of recurrence or death from any cause
Measured: 3 years
Disease Control Rate (DCR)
Percentage of participants who achieved a best overall response of CR or PR or Stable Disease (SD).
Measured: 3 years
Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria In Solid Tumors(mRECIST) v1.1
Objective response referred to participants with complete response (CR) or partial response (PR). CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: greater than or equal to (>=) 30% decrease in sum of the longest diameter (LD) of all target lesions taking as reference the screening sum LD. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.
Measured: within 3 weeks after surgery
Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC Quality of Life Questionnaire (QLQ)-C30) Score
The EORTC QLQ-C30 is a validated, cancer-specific 30-item patient-reported measure, and contains 14 domains to assess the impact of cancer treatment on 5 aspects of participants functioning (physical, role, cognitive, emotional, and social), 9 aspects of disease/treatment-related symptoms (fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation, diarrhea) and a global QoL/overall health status scale. Questions used 4 point scale (1 'Not at all' to 4 'Very much'; with the exception of the QoL/health status scale which uses a 7-point scale (1 'very poor' to 7 'Excellent'). Each scale is transformed on a scale of 0-100; a higher score equals (=) a better level of functioning or greater degree of symptoms. Change of greater than or equal to (>=) 10-points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.
Measured: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at follow-up
Adverse events
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.The number of Participants with adverse events will be recorded at each treatment visit.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start1 Dec 2017
- Primary completion30 Dec 2019
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Junction AdenocarcinomaStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qun Zhao, Hebei Medical University
- Investigators
- Qun Zhao, Principal investigator, Hebei Medical University Fourth HospitalJun Wang, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368131
- Sponsor's protocol ID
- Alien Crafe 0005
- Status last verified
- Feb 2020
- First submitted
- 5 Dec 2017
- Last updated
- 19 Feb 2020
- 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 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Concurrent Neoadjuvant Chemoradiotherapy Plus Trastuzumab for Siewert II ，III of HER-2 Positive Adenocarcinoma at Gastroesophageal Junction
- ClinicalTrials.gov ID
- NCT03368131
- Acronym / sponsor ID
- Alien Crafe 0005
- Conditions
- Gastroesophageal Junction Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 11 Dec 2017 (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 purpose of this study is to assess the efficacy and safety of patients who receive concurrent neoadjuvant chemoradiotherapy for Siewert II ，III of locally advanced HER-2 Positive adenocarcinoma at gastroesophageal junction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab XELOX and radiotherapy | Experimental | Drug: Trastuzumab, Drug: Capecitabine, Drug: Oxaliplatin, Radiation: RadiotherapyTrastuzumab is intravenously administered with the loading dose of 8 mg/kg followed by maintenance dose of 6mg/kg in day 1 of each cycle. XELOX：Capecitabine 825~1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy：45 Gray (unit)Gy/25f （1.8Gy/f/d，5 f/w） |
| XELOX and radiotherapy | Active comparator | Drug: Capecitabine, Drug: Oxaliplatin, Radiation: RadiotherapyCapecitabine：825~1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy：45Gy/25f （1.8Gy/f/d，5 f/w） |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age:18 to 60 years old (man or female);
- confirmed to Siewert II , III of locally advanced adenocarcinoma at gastroesophageal junction. The her-2 positive was detected by immunohistochemistry or Fluorescence in SituHybridization(FISH);
- Patients with Stage for Ⅲ by Endorectal Ultrasonography( EUS), Computed Tomography(CT) (or Positron Emission Tomography(PET )-CT) and laparoscopic (According to the eighth edition of American Joint Committee on Cancer (AJCC) );
- Patients are diagnosed as potentially resectable by multidisciplinary team, no surgical contraindications, and expected to be surgical resection;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
Key exclusion criteria (10 listed)
- Allergic to trastuzumab, capecitabine and oxaliplatin;
- severe diseases such as liver and kidney，myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia，which affect the situation of chemotherapy or surgery
- A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc);
- Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +); Has melena and hematemesis in two months;
- Coagulant function abnormality (International Normalized Ratio(INR) > 1.5 ULN, Activated Partial Thromboplastin Time(APTT ) > 1.5 ULN), with bleeding tendency;
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 |
|---|---|---|
| Trastuzumabintravenously administered with the loading dose of 8 mg/kg followed by maintenance dose of 6mg/kg in day 1 of each cycle | Drug | Trastuzumab XELOX and radiotherapy |
| Capecitabine825~1000mg/m2 bid d1-14 | Drug | Trastuzumab XELOX and radiotherapy, XELOX and radiotherapy |
| Oxaliplatin130 mg/m2 Ivgtt d1 q3w | Drug | Trastuzumab XELOX and radiotherapy, XELOX and radiotherapy |
| Radiotherapy45 Gray (unit) Gy/25f （1.8Gy/f/d，5 f/w） | Radiation | Trastuzumab XELOX and radiotherapy, XELOX and radiotherapy |
Primary outcome
The pathological complete response rate(pCR)
Time frame: within 3 weeks after surgery
The lesion disappeared completely by pathology
6 secondary outcomes
Overall survival (OS)
Time frame: 3 years
Disease-free survival(DFS)
Time frame: 3 years
Disease Control Rate (DCR)
Time frame: 3 years
Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria In Solid Tumors(mRECIST) v1.1
Time frame: within 3 weeks after surgery
Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC Quality of Life Questionnaire (QLQ)-C30) Score
Time frame: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at follow-up
Adverse events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
Related trials for Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 2
Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric or Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 2
Candonilimab Combined With Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
Stomach Neoplasms
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.
Qun Zhao principal investigator
Hebei Medical University Fourth Hospital
Jun Wang principal investigator
Hebei Medical University Fourth Hospital
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 Trastuzumab, Capecitabine and Oxaliplatin in people with Gastroesophageal Junction Adenocarcinoma, run by Hebei 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 10 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 19 Feb 2020. 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?
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?
The pathological complete response rate(pCR) (time frame: within 3 weeks after 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 19 Feb 2020.