Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)Phase 2NCT05942573
Continuation of Serplulimab Plus Chemotherapy After First Progression in Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma: an Open-label, Randomised Phase II Trial
A Phase 2 study testing Serplulimab+Paclitaxel+Apatinib and Paclitaxel±Ramucirumab in people with Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer(patients with HER2 negative and PD-L1 CPS≥5).Patiens will recevie Serplulimab plus chemotherapy ((oxaliplatin+capecitabine) as first-line treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)
- What is being tested?
- Serplulimab+Paclitaxel+Apatinib and Paclitaxel±Ramucirumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2022to 31 Dec 2024
- 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
- Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
- Age ≥ 18 years and ≤ 75 years when ICF is signed;
- Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma;
- never received systemic anti-tumor drug therapy before；
- HER2 negative and PD-L1 CPS≥5;
- Measurable lesion according to RECIST v1.1 by IRRC;
- ECOG score 0-1;
Who cannot join
- Has other active malignancies within 5 years before the first administration of the study drug;
- Plan to or have previously received organ or bone marrow transplantation;
- Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
- Have received any research drugs within 14 days before the first use of the study drugs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Ming Bai, MD, +8613820741351, bmmhead1982@126.com
Ting Deng, MD
About this study
Official title: SCAFIGC：Continuation of Serplulimab Plus Chemotherapy After First Progression in Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma: an Open-label, Randomised Phase II Trial
This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer(patients with HER2 negative and PD-L1 CPS≥5).Patiens will recevie Serplulimab plus chemotherapy ((oxaliplatin+capecitabine) as first-line treatment. After PD，patients will randomly 2：1 assigned to treatment：one group will receive Serpluimab with Paclitaxel,Apatinib；another group will receive Paclitaxel with or without Ramucirumab.All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent
Read the detailed description
stage one ：Serplulimab 3mg/kg,d1,q2w or 4.5mg/kg,d1,q3w+oxaliplatin130mg/m2 iv.gtt d1+capecitabine 1000mg/m2 p.o.b.i.d d1~d14,q3w
stage two:Serplulimab 3mg/kg,d1,q2w or 4.5mg/kg,d1,q3w+Apatinib 250mg/qd+Paclitaxel 135~175mg/m2 iv.gtt,d1,q3w
Paclitaxel 135~175mg/m2 iv.gtt,d1,q3w±Ramucirumab 8mg/kg,d1,q2w
- Being tested
- Serplulimab+Paclitaxel+Apatinib, Paclitaxel±Ramucirumab
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serplulimab+Paclitaxel+ApatinibDrug
Also called A:Drug:Serplulimab+paclitaxel+Apatinib
Immunotherapy+chemotherapy
Paclitaxel±RamucirumabDrug
Also called B:Drug:paclitaxel±Ramucirumab
chemotherapy±Targeted therapy
| Study group | Role | What they receive |
|---|---|---|
| continuation of Serplulimab plus chemotherapy after first progression | Experimental | Serplulimab+Paclitaxel+Apatinib
Paclitaxel±Ramucirumab Receives: Drug: Serplulimab+Paclitaxel+Apatinib; Drug: Paclitaxel±Ramucirumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month PFS%
Progression-free survival by IRRC assessment per RECIST 1.1
Measured: The Percent of patinets after first progression until disease progression in 6 months
Secondary outcomes (3)
OS
Overall survival
Measured: From the date of first dose unitl the date of death from any cause，assessed up to 2 years ]
PFS2
Progression-free survival by IRRC assessment per RECIST 1.1
Measured: From date of randomization until the date of second-line treatment progression or date of death from any cause, whichever came first
PFS1
Progression-free survival by IRRC assessment per RECIST 1.1
Measured: From date of randomization until the date of first documented progressionor date of death from any cause, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start24 Dec 2022
- Primary completionOct 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)Studies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Serplulimab
- Masking
- None (open label)
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942573
- Sponsor's protocol ID
- SCAFIGC
- Status last verified
- Oct 2022
- First submitted
- 17 Apr 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCAFIGC：Continuation of Serplulimab Plus Chemotherapy After First Progression in Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma: an Open-label, Randomised Phase II Trial
- ClinicalTrials.gov ID
- NCT05942573
- Acronym / sponsor ID
- SCAFIGC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 24 Dec 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Jul 2023 (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 study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer(patients with HER2 negative and PD-L1 CPS≥5).Patiens will recevie Serplulimab plus chemotherapy ((oxaliplatin+capecitabine) as first-line treatment. After PD，patients will randomly 2：1 assigned to treatment：one group will receive Serpluimab with Paclitaxel,Apatinib；another group will receive Paclitaxel with or without Ramucirumab.All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent
Detailed description
stage one ：Serplulimab 3mg/kg,d1,q2w or 4.5mg/kg,d1,q3w+oxaliplatin130mg/m2 iv.gtt d1+capecitabine 1000mg/m2 p.o.b.i.d d1~d14,q3w
stage two:Serplulimab 3mg/kg,d1,q2w or 4.5mg/kg,d1,q3w+Apatinib 250mg/qd+Paclitaxel 135~175mg/m2 iv.gtt,d1,q3w
Paclitaxel 135~175mg/m2 iv.gtt,d1,q3w±Ramucirumab 8mg/kg,d1,q2w
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Serplulimab
| Arm | Type | Receives |
|---|---|---|
| continuation of Serplulimab plus chemotherapy after first progression | Experimental | Drug: Serplulimab+Paclitaxel+Apatinib, Drug: Paclitaxel±RamucirumabSerplulimab+Paclitaxel+Apatinib Paclitaxel±Ramucirumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
- Age ≥ 18 years and ≤ 75 years when ICF is signed;
- Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma;
- never received systemic anti-tumor drug therapy before；
- HER2 negative and PD-L1 CPS≥5;
Key exclusion criteria (4 listed)
- Has other active malignancies within 5 years before the first administration of the study drug;
- Plan to or have previously received organ or bone marrow transplantation;
- Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
- Have received any research drugs within 14 days before the first use of the study drugs.
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 |
|---|---|---|
| Serplulimab+Paclitaxel+ApatinibAlso: A:Drug:Serplulimab+paclitaxel+ApatinibImmunotherapy+chemotherapy | Drug | continuation of Serplulimab plus chemotherapy after first progression |
| Paclitaxel±RamucirumabAlso: B:Drug:paclitaxel±Ramucirumabchemotherapy±Targeted therapy | Drug | continuation of Serplulimab plus chemotherapy after first progression |
Primary outcome
6-month PFS%
Time frame: The Percent of patinets after first progression until disease progression in 6 months
Progression-free survival by IRRC assessment per RECIST 1.1
3 secondary outcomes
OS
Time frame: From the date of first dose unitl the date of death from any cause，assessed up to 2 years ]
PFS2
Time frame: From date of randomization until the date of second-line treatment progression or date of death from any cause, whichever came first
PFS1
Time frame: From date of randomization until the date of first documented progressionor date of death from any cause, whichever came first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
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 Serplulimab+Paclitaxel+Apatinib and Paclitaxel±Ramucirumab in people with Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ), run by Tianjin Medical University Cancer Institute and Hospital 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 7 inclusion and 4 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 12 Jul 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month PFS% (time frame: The Percent of patinets after first progression until disease progression in 6 months). 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 12 Jul 2023.