Advanced Gastric and Gastro-esophageal Junction AdenocarcinomaPhase 2NCT04140318
Sintilimab and Nab-paclitaxel in Second-line Treatment of Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma
A Phase 2 study testing sintilimab and nab-paclitaxel in people with Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Sintilimab (PD-1 inhibitor) and nab-paclitaxel in second line treatment of advanced gastric and gastro-esophageal junction adenocarcinoma. This is a prospective, multi-centers, single arm phase II trial with primary objective overall response rate and second objective of safety… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma
- What is being tested?
- sintilimab and nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2019to 1 Feb 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathological confirmed advanced gastric and gastro-esophageal junction adenocarcinoma;
- progression after first-line treatment of fluoropyrimidine and platinum, allow patients progressed on/within 6 months of neoadjuvant/adjuvant treatment; allow local radiotherapy after 21days later;
- 18-75 years old;
- ECOG: 0 or 1;
- has adequate organ function
- writen ICF;
Who cannot join
- previous treated with taxanes (including paclitaxel, nab-PTX, lipo-PTX, and docetaxel etc..);
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody;
- has known active central nervous system metastatases;
- has received a live vaccine within 4 weeks prior to the first dose of study treatment with any acitve autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatititis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
- clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), orventricular arrhythmia which need medical intervention.
- hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg. coagulation abnormalities (INR > 1.5 or APTT > 1.5×ULN), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences
Beijing, 10000
Ai ping Zhou, 8610-87788145, zhouap1825@126.com
About this study
Official title: Efficacy and Safety of Sintilimab and Nab-paclitaxel in Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma Patients With Progression After Fluoropyrimidine or Platinum, a Multi-center, Phase II, Single Arm Trial
To evaluate the efficacy and safety of Sintilimab (PD-1 inhibitor) and nab-paclitaxel in second line treatment of advanced gastric and gastro-esophageal junction adenocarcinoma. This is a prospective, multi-centers, single arm phase II trial with primary objective overall response rate and second objective of safety and other efficacy endpoints.
- Being tested
- sintilimab, nab-paclitaxel
- Keywords
- second line, PD-1, nab-paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sintilimabDrug
Sintilimab 200mg, iv, 30-60min, q3w;
nab-paclitaxelDrug
Nab-paclitaxel: 125 mg/m2 iv d1、d8, q3w
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | combination therapy of PD-1 and chemotherapy including: sintilimab 200mg iv, 30-60min, q3w; nab-paclitaxel 125mg/m2, iv, d1,d8, q3w Receives: Drug: sintilimab; Drug: nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Measured: up to two years
Secondary outcomes (5)
DCR
disease control rate
Measured: up to three years
DOR
duration of response
Measured: up to three years
AE
treatment related adverse event
Measured: from first dose to 90days of last dose
PFS
progression free survival
Measured: up to three years
OS
overall survival
Measured: up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start15 Nov 2019
- Primary completion30 Aug 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric and Gastro-esophageal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, Beijing Friendship Hospital, Beijing Hospital
- Responsible party
- Principal investigator, Aiping Zhou, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140318
- Sponsor's protocol ID
- NCC2070
- Status last verified
- Mar 2022
- First submitted
- 24 Oct 2019
- Last updated
- 11 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The baseline characteristics of patients could be shared to othter researchers per request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sintilimab and Nab-paclitaxel in Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma Patients With Progression After Fluoropyrimidine or Platinum, a Multi-center, Phase II, Single Arm Trial
- ClinicalTrials.gov ID
- NCT04140318
- Acronym / sponsor ID
- NCC2070
- Keywords
- second line, PD-1, nab-paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Beijing Friendship Hospital, Beijing Hospital
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 25 Oct 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.
To evaluate the efficacy and safety of Sintilimab (PD-1 inhibitor) and nab-paclitaxel in second line treatment of advanced gastric and gastro-esophageal junction adenocarcinoma. This is a prospective, multi-centers, single arm phase II trial with primary objective overall response rate and second objective of safety and other efficacy endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: sintilimab, Drug: nab-paclitaxelcombination therapy of PD-1 and chemotherapy including: sintilimab 200mg iv, 30-60min, q3w; nab-paclitaxel 125mg/m2, iv, d1,d8, q3w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- pathological confirmed advanced gastric and gastro-esophageal junction adenocarcinoma;
- progression after first-line treatment of fluoropyrimidine and platinum, allow patients progressed on/within 6 months of neoadjuvant/adjuvant treatment; allow local radiotherapy after 21days later;
- 18-75 years old;
- ECOG: 0 or 1;
- has adequate organ function
Key exclusion criteria (6 listed)
- previous treated with taxanes (including paclitaxel, nab-PTX, lipo-PTX, and docetaxel etc..);
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody;
- has known active central nervous system metastatases;
- has received a live vaccine within 4 weeks prior to the first dose of study treatment with any acitve autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatititis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
- clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), orventricular arrhythmia which need medical intervention.
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 |
|---|---|---|
| sintilimabSintilimab 200mg, iv, 30-60min, q3w; | Drug | treatment |
| nab-paclitaxelNab-paclitaxel: 125 mg/m2 iv d1、d8, q3w | Drug | treatment |
Primary outcome
ORR
Time frame: up to two years
5 secondary outcomes
DCR
Time frame: up to three years
DOR
Time frame: up to three years
AE
Time frame: from first dose to 90days of last dose
PFS
Time frame: up to three years
OS
Time frame: up to three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: Undecided. The baseline characteristics of patients could be shared to othter researchers per request.
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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.
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 sintilimab and nab-paclitaxel in people with Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma, run by Chinese Academy of Medical Sciences 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 6 inclusion and 6 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 11 Mar 2022. 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 Aiping Zhou, MD (8687788145, zhouap1825@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to two 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 11 Mar 2022.