Gastric CancerPhase 2NCT04358341
Pegliposomal Doxorubicin and 5-fluorouracil as Second Line Therapy for Metastatic Gastric Cancer
A Phase 2 study testing Irinotecan, DOXOrubicin Liposome Injection and 5fluorouracil in people with Gastric Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
For second-line chemotherapy for metastatic gastric cancer, single-agent irinotecan is the standard treatment. Anthracyclines are active but lack well designed investigations. The combination of epirubicin, fluorouracil and cisplatin (or oxaliplatin) are widely used in Europe. 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?
- Irinotecan, DOXOrubicin Liposome Injection and 5fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2020to 1 Dec 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old;
- Metastatic gastric cancer progressed on first-line treatment;
- Expected survival time ≥ 3 months;
- At least one evaluable target lesion according to the solid tumor evaluation criteria (RECIST) version 1.1;
- ECOG PS 0~2;
- Adequate bone marrow function reserve: white blood cell count ≥ 3.0 × 10*9 / L, neutrophil count ≥ 1.5 × 10*9/ L; platelet count ≥ 100 ×10*9/ L; hemoglobin ≥ 90 g / L;
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- Adequate liver and renal function reserve: AST and ALT ≤ 2.5 times the upper limit of normal value, total bilirubin ≤ 2 times the upper limit of normal value; serum creatinine ≤ 1.5 times the upper limit of normal value;
- LVEF ≥ 55 %;
- Be able to understand the research process, volunteer to participate in the study, and sign an informed consent form.
Who cannot join
- Patients known to be allergic to active or other components of chemotherapeutic drugs;
- Patients who have been treated with PLD or irinotecan in the past;
- According to the researcher's judgment, other anti-tumor treatments such as radiotherapy and surgical resection are required during chemotherapy;
- Those who are not expected to be able to tolerate chemotherapy with severe heart disease or discomfort;
- d-MMR or MSI-H or Her-2 overexpression;
- Severe or uncontrolled infections or diabetes;
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- History of other malignacis in the past 5 years (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin);
- Participated in other clinical trials within 4 weeks prior to the start of the study;
- Pregnant or lactating women, or women of childbearing age who refuse to take effective contraception during the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jian Xiao
Guangzhou, Guangdong, 510655
Jian Xiao, MD, 862038285497 ext. 862038285497, xiaoj26@mail.sysu.edu.cn
About this study
Official title: Phase II Study of Pegliposomal Doxorubicin and 5-fluorouracil Compared With Irinotecan as Second Line Therapy for Metastatic Gastric Cancer.
For second-line chemotherapy for metastatic gastric cancer, single-agent irinotecan is the standard treatment. Anthracyclines are active but lack well designed investigations. The combination of epirubicin, fluorouracil and cisplatin (or oxaliplatin) are widely used in Europe. However, traditional anthracyclines are more cardiotoxic; and (Pegliposomal Doxorubicin) PLD, as a new liposome dosage form of doxorubicin, has better cardiac safety. Therefore, we designed this phase II trial with PLD and 5-Fu to compare irinotecan monotherapy in the second-line treatment.
Read the detailed description
Patients with metastatic gastric cancer failed to first-line therapy will be radomized to arm A with PLD and 5-Fu and arm B with irinotecan single agent therapy. Both regimens will be treated every 2 weeks until disease progression or untolerable toxicity. Efficacy will be assessed every 3 cycles and safety will be evaluated every cycle.
- Conditions
- Gastric Cancer
- Being tested
- Irinotecan, DOXOrubicin Liposome Injection, 5fluorouracil
- Keywords
- Pegliposomal Doxorubicin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
Also called CPT-11
150 mg/m2 ivdrip every 14 days
DOXOrubicin Liposome InjectionDrug
Also called Pegliposomal Doxorubicin
25 mg/m2 ivdrip every 14 days
5fluorouracilDrug
Also called 5-FU
400mg/m2 iv bolus and 2400 mg/m2 civ 46h every 14 days
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan alone | Active comparator | 150 mg/m2 iv drip d1; Repeat every 14 days. Receives: Drug: Irinotecan |
| Pegliposomal Doxorubicin and 5-FU | Experimental | Pegliposomal Doxorubicin: 25mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ 46h d1; Repeat every 14 days. Receives: Drug: DOXOrubicin Liposome Injection; Drug: 5fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate (DCR)
Percentage of subjects with tumor shrinkage reaching complete response (CR), partial response (PR) and disease stabilization (SD).
Measured: 24 weeks
Secondary outcomes (5)
Objective response rate (ORR)
Percentage of subjects with tumor shrinkage reaching complete response (CR) and partial remission (PR).
Measured: 24 weeks
Progression-Free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease or date of death, whichever occurs first. For target lesions (TL), PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD) of TLs, taking as a reference the smallest SLD recorded since the treatment started, or the appearance of one or more lesions. For non-target lesions (NTL), PD was defined as an unequivocal progression of existing NTLs. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.
Measured: 1 year
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log or the date of last follow-up.
Measured: 2 years
Treatment associated toxicities
According to WHO CTC 3.0
Measured: 2 years
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
The QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.
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 posted24 Apr 2020
- Study start17 Jun 2020
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Dec 2022 (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 Sixth Affiliated Hospital, Sun Yat-sen 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
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Jian Xiao, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358341
- Sponsor's protocol ID
- SAHMO205
- Status last verified
- Aug 2020
- First submitted
- 13 Apr 2020
- Last updated
- 24 Aug 2020
- 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 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Pegliposomal Doxorubicin and 5-fluorouracil Compared With Irinotecan as Second Line Therapy for Metastatic Gastric Cancer.
- ClinicalTrials.gov ID
- NCT04358341
- Acronym / sponsor ID
- SAHMO205
- Conditions
- Gastric Cancer
- Keywords
- Pegliposomal Doxorubicin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 24 Apr 2020 (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.
For second-line chemotherapy for metastatic gastric cancer, single-agent irinotecan is the standard treatment. Anthracyclines are active but lack well designed investigations. The combination of epirubicin, fluorouracil and cisplatin (or oxaliplatin) are widely used in Europe. However, traditional anthracyclines are more cardiotoxic; and (Pegliposomal Doxorubicin) PLD, as a new liposome dosage form of doxorubicin, has better cardiac safety. Therefore, we designed this phase II trial with PLD and 5-Fu to compare irinotecan monotherapy in the second-line treatment.
Detailed description
Patients with metastatic gastric cancer failed to first-line therapy will be radomized to arm A with PLD and 5-Fu and arm B with irinotecan single agent therapy. Both regimens will be treated every 2 weeks until disease progression or untolerable toxicity. Efficacy will be assessed every 3 cycles and safety will be evaluated every cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irinotecan alone | Active comparator | Drug: Irinotecan150 mg/m2 iv drip d1; Repeat every 14 days. |
| Pegliposomal Doxorubicin and 5-FU | Experimental | Drug: DOXOrubicin Liposome Injection, Drug: 5fluorouracilPegliposomal Doxorubicin: 25mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ 46h d1; Repeat every 14 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-70 years old;
- Metastatic gastric cancer progressed on first-line treatment;
- Expected survival time ≥ 3 months;
- At least one evaluable target lesion according to the solid tumor evaluation criteria (RECIST) version 1.1;
- ECOG PS 0~2;
Key exclusion criteria (9 listed)
- Patients known to be allergic to active or other components of chemotherapeutic drugs;
- Patients who have been treated with PLD or irinotecan in the past;
- According to the researcher's judgment, other anti-tumor treatments such as radiotherapy and surgical resection are required during chemotherapy;
- Those who are not expected to be able to tolerate chemotherapy with severe heart disease or discomfort;
- d-MMR or MSI-H or Her-2 overexpression;
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 |
|---|---|---|
| IrinotecanAlso: CPT-11150 mg/m2 ivdrip every 14 days | Drug | Irinotecan alone |
| DOXOrubicin Liposome InjectionAlso: Pegliposomal Doxorubicin25 mg/m2 ivdrip every 14 days | Drug | Pegliposomal Doxorubicin and 5-FU |
| 5fluorouracilAlso: 5-FU400mg/m2 iv bolus and 2400 mg/m2 civ 46h every 14 days | Drug | Pegliposomal Doxorubicin and 5-FU |
Primary outcome
Disease control rate (DCR)
Time frame: 24 weeks
Percentage of subjects with tumor shrinkage reaching complete response (CR), partial response (PR) and disease stabilization (SD).
5 secondary outcomes
Objective response rate (ORR)
Time frame: 24 weeks
Progression-Free Survival (PFS)
Time frame: 1 year
Overall Survival (OS)
Time frame: 2 years
Treatment associated toxicities
Time frame: 2 years
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
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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.
Jian Xiao, MD principal investigator
Sun Yat-sen 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 Irinotecan, DOXOrubicin Liposome Injection and 5fluorouracil in people with Gastric Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen 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 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 24 Aug 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?
Contact Xiaohui Zhai, MD (862038285497 ext. 862038285497, zhaixh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (DCR) (time frame: 24 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 24 Aug 2020.