Successful Conversion Rate of OperationEarly Phase 1NCT03822130
Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate for Unresectable Gastric Cancer
A Early Phase 1 study testing Arterial catheter infusion chemotherapy, Sodium Bicarbonate and Systemic Chemotherapy in people with Successful Conversion Rate of Operation and Unresectable Gastric Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This project intends to compare the clinical effects and side effects of three kinds of treatment methods in the treatment of unresectable gastric cancer by intra-arterial catheter infusion chemotherapy combined with sodium bicarbonate and systemic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Successful Conversion Rate of Operation, Unresectable Gastric Cancer
- What is being tested?
- Arterial catheter infusion chemotherapy, Sodium Bicarbonate and Systemic Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 31 Dec 2020
- Phase
- Early Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 75 years;
- Ultrasound gastroscopy or imaging (CT) can diagnose potentially unresectable gastric cancer (T4a-bN2-3M0) with indications of neoadjuvant chemotherapy or transformation therapy;
- Pathological diagnosis of gastric cancer;
- No contraindication of chemotherapy;
- Patients who did not undergo chemotherapy or were diagnosed for the first time.
Who cannot join
- Those who fail to comply with the requirements of the trial, obviously violate this regimen, or change to other regimens in the course of treatment;
- The life expectancy of patients with extensive systemic metastasis is less than 3 months;
- Leukocyte count is less than 2*109/L and platelet count is less than 75*10^9/L;
- Severe heart, liver and kidney diseases, unable to tolerate chemotherapy;
- Patients without gastric cancer complications such as massive gastrointestinal bleeding and perforation need to be treated in emergency department;
- Patients with distant metastasis (excluding group 16 lymph node metastasis);
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- Patients with other tumors, with a history of malignant tumors (excluding early primary cancers);
- The patient himself asked to withdraw from the trial;
- Researchers believe that patients are not suitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Min Chao, +86 13957139239, z2doctor_chaoming@163.com
About this study
Official title: A Randomized Controlled Trial for Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate and Systemic Chemotherapy for Unresectable Gastric Cancer
This project intends to compare the clinical effects and side effects of three kinds of treatment methods in the treatment of unresectable gastric cancer by intra-arterial catheter infusion chemotherapy combined with sodium bicarbonate and systemic chemotherapy. It is clear that intra-arterial catheter infusion chemotherapy combined with sodium bicarbonate is not suitable for the treatment of unresectable gastric cancer. The clinical practice value of resection of gastric cancer can provide high quality evidence-based medical basis for the treatment guidelines of advanced gastric cancer, and explore a new clinical technology with exact curative effect and higher safety.
- Being tested
- Arterial catheter infusion chemotherapy, Sodium Bicarbonate, Systemic Chemotherapy, Oral Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial catheter infusion chemotherapyDrug
Arterial catheter infusion chemotherapy
Sodium BicarbonateDrug
Arterial catheter infusion Sodium Bicarbonate
Systemic ChemotherapyDrug
Systemic Chemotherapy
Oral ChemotherapyDrug
Oral Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | Systemic Chemotherapy + Oral Chemotherapy Group Receives: Drug: Systemic Chemotherapy; Drug: Oral Chemotherapy |
| Group 2 | Experimental | Arterial catheter infusion chemotherapy plus oral chemotherapy group Receives: Drug: Arterial catheter infusion chemotherapy; Drug: Oral Chemotherapy |
| Group 3 | Experimental | Arterial catheter infusion chemotherapy + sodium bicarbonate plus oral chemotherapy group Receives: Drug: Arterial catheter infusion chemotherapy; Drug: Sodium Bicarbonate; Drug: Oral Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful conversion rate of operation
Measured: 42 days
Secondary outcomes (2)
ORR
Objective Response rate
Measured: 42 days
PFS
progression-free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Feb 2019
- Primary completion31 Dec 2020 (estimated)
- 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 Successful Conversion Rate of OperationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822130
- Sponsor's protocol ID
- IR2018001142
- Status last verified
- Jan 2019
- First submitted
- 23 Jan 2019
- Last updated
- 20 Feb 2019
- 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 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial for Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate and Systemic Chemotherapy for Unresectable Gastric Cancer
- ClinicalTrials.gov ID
- NCT03822130
- Acronym / sponsor ID
- IR2018001142
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 Jan 2019 (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 project intends to compare the clinical effects and side effects of three kinds of treatment methods in the treatment of unresectable gastric cancer by intra-arterial catheter infusion chemotherapy combined with sodium bicarbonate and systemic chemotherapy. It is clear that intra-arterial catheter infusion chemotherapy combined with sodium bicarbonate is not suitable for the treatment of unresectable gastric cancer. The clinical practice value of resection of gastric cancer can provide high quality evidence-based medical basis for the treatment guidelines of advanced gastric cancer, and explore a new clinical technology with exact curative effect and higher safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Drug: Systemic Chemotherapy, Drug: Oral ChemotherapySystemic Chemotherapy + Oral Chemotherapy Group |
| Group 2 | Experimental | Drug: Arterial catheter infusion chemotherapy, Drug: Oral ChemotherapyArterial catheter infusion chemotherapy plus oral chemotherapy group |
| Group 3 | Experimental | Drug: Arterial catheter infusion chemotherapy, Drug: Sodium Bicarbonate, Drug: Oral ChemotherapyArterial catheter infusion chemotherapy + sodium bicarbonate plus oral chemotherapy group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 to 75 years;
- Ultrasound gastroscopy or imaging (CT) can diagnose potentially unresectable gastric cancer (T4a-bN2-3M0) with indications of neoadjuvant chemotherapy or transformation therapy;
- Pathological diagnosis of gastric cancer;
- No contraindication of chemotherapy;
- Patients who did not undergo chemotherapy or were diagnosed for the first time.
Key exclusion criteria (9 listed)
- Those who fail to comply with the requirements of the trial, obviously violate this regimen, or change to other regimens in the course of treatment;
- The life expectancy of patients with extensive systemic metastasis is less than 3 months;
- Leukocyte count is less than 2*109/L and platelet count is less than 75*10^9/L;
- Severe heart, liver and kidney diseases, unable to tolerate chemotherapy;
- Patients without gastric cancer complications such as massive gastrointestinal bleeding and perforation need to be treated in emergency department;
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 |
|---|---|---|
| Arterial catheter infusion chemotherapyArterial catheter infusion chemotherapy | Drug | Group 2, Group 3 |
| Sodium BicarbonateArterial catheter infusion Sodium Bicarbonate | Drug | Group 3 |
| Systemic ChemotherapySystemic Chemotherapy | Drug | Group 1 |
| Oral ChemotherapyOral Chemotherapy | Drug | Group 1, Group 2, Group 3 |
Primary outcome
Successful conversion rate of operation
Time frame: 42 days
2 secondary outcomes
ORR
Time frame: 42 days
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Arterial catheter infusion chemotherapy, Sodium Bicarbonate and Systemic Chemotherapy in people with Successful Conversion Rate of Operation and Unresectable Gastric Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 5 inclusion and 9 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 20 Feb 2019. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Contact Ming Chao (+86 13957139239, z2doctor_chaoming@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful conversion rate of operation (time frame: 42 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 20 Feb 2019.