Metastatic or Recurrent Gastric AdenocarcinomaPhase 2NCT05237349
Envafolimab Combined With Chemotherapy in Metastatic or Recurrent Gastric Adenocarcinoma
A Phase 2 study testing Envafolimab, Oxaliplatin and S1 in people with Metastatic or Recurrent Gastric Adenocarcinoma, run by Liangjun Zhu M.M. at 1 site in China.
Trial summary
The objective is to investigate the efficacy and safety of Envafolimab combined with chemotherapy in the treatment of metastatic or recurrent gastric adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic or Recurrent Gastric Adenocarcinoma
- What is being tested?
- Envafolimab, Oxaliplatin and S1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 1 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
- 18-75 years；
- ECOG 0-1；
- life expectancy of at least 3 months；
- Negative for HER2 gene expression by central laboratory ；
- The tumor expresses PD-L1 as detected by the central laboratory, and the tumor proportion score (CPS) ≥ 1；
- At least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm（according to RECIST 1.1）；
Show all 10Show fewer
- Diagnosed by histology and/or cytology, and assessed by imaging (refer to RECIST 1.1) as advanced metastatic gastric adenocarcinoma or gastric adenocarcinoma that has recurred after previous gastric cancer surgery;
- Not received systemic chemotherapy in the past. Patients who have previously received fluorouracil monotherapy or fluorouracil-based adjuvant therapy or neoadjuvant therapy, and patients who have completed adjuvant therapy or neoadjuvant therapy before the start of the chemotherapy regimen in this trial 6 months ago can be included in this trial. In cases of metastatic disease requiring local remission, remission therapy with radiosensitizing doses of fluorouracil or capecitabine alone is permitted only ；
- satisfactory main organ function，laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count（ANC） ≥1.5×109/L, platelet count（PLT） ≥80×109/L, Serum creatinine（CR）≤1.5 upper normal limitation (UNL)，total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN; left ventricular ejection fraction (LVEF) ≥ 50%; thyroid stimulating hormone (TSH) within the normal range Within: if the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
- Subjects of childbearing potential must use an appropriate method of contraception during the study period and within 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects ；
Who cannot join
- Suffered from other malignant tumors within 5 years before the start of treatment in this study;
- Pathologically suggested patients with abnormally increased AFP OR MSI-H ；
- Grade ≥1 unresolved toxicities (according to the most recent version of the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]) due to any prior therapy, excluding alopecia and fatigue; neurotoxicity was Recovery to ≤ grade 1 or baseline before the group;
- Subjects with any severe and/or uncontrolled disease ；
- Poorly controlled diabetes (fasting blood glucose [FBG] > 10 mmol/L) ；
- Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment; or had a long-term unhealed wound or fracture；
Show all 11Show fewer
- Serious arterial/venous thrombotic event within 6 months prior to initiation of study treatment ；
- Previously received drug therapy against PD-1, PD-L1 and other related immune checkpoints ；
- Participating in or participating in other clinical investigators within 4 weeks prior to the start of the study ；
- Allergic to the active ingredients or excipients of the study drug ；
- Unsuitable for the study or other chemotherapy determined by investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, 210009
Zhu Liangjun, +8613905199123, zhulj98@foxmail.com
Li Sheng, +8613770768636, lihsh198@163.com
About this study
Official title: A Prospective, Single-arm Clinical Trial of Envafolimab Combined With Chemotherapy in Metastatic or Recurrent Gastric Adenocarcinoma
The objective is to investigate the efficacy and safety of Envafolimab combined with chemotherapy in the treatment of metastatic or recurrent gastric adenocarcinoma.
Read the detailed description
Envafolimab indication: Envafolimab is the world's first subcutaneous injection of PD-L1 monoclonal antibody.Suitable for adult patients with advanced solid tumors with unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects (dMMR).
- Being tested
- Envafolimab, Oxaliplatin, S1
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnvafolimabDrug
Also called Immunotherapy
300mg,sc,d1,Q3W
OxaliplatinDrug
Also called Chemotherapy
130mg/m2, iv,d1,Q3W
S1Drug
Also called Chemotherapy
40mg/m2, op,bid,d1-14,Q3W
| Study group | Role | What they receive |
|---|---|---|
| envafolimab plus chemotherapy | Experimental | Envafolimab:300mg,sc,d1,Q3W; Chemotherapy:SOX(Oxaliplatin，130mg/m2, iv,d1,Q3W + S-1，40mg/m2, op,bid,d1-14,Q3W). Receives: Drug: Envafolimab; Drug: Oxaliplatin; Drug: S1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate
Measured: 6 months
Secondary outcomes (6)
PFS
Progression Free Survival
Measured: 6 months
OS
Overall Survival
Measured: 12 months
DCR
Disease Control Rate
Measured: 9 months
DOR
Duration of Response
Measured: 12 months
AEs
Percentage of participants experiencing grade 3-5 adverse events
Measured: 12 months
Qualify of Life
Based on Quality of Life Questionnare-Core 30, evaluate the quality of life of patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Mar 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic or Recurrent Gastric 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liangjun Zhu M.M.
- Sponsor type
- University, hospital or other
- Collaborators
- Zhangjiagang First People's Hospital
- Responsible party
- Sponsor-investigator, Liangjun Zhu M.M., Jiangsu Cancer Institute & Hospital
- Investigators
- Liangjun Zhu, Study chair, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237349
- Sponsor's protocol ID
- SMA-GC-001
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2022
- Last updated
- 5 Jan 2024
- 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm Clinical Trial of Envafolimab Combined With Chemotherapy in Metastatic or Recurrent Gastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05237349
- Acronym / sponsor ID
- SMA-GC-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Liangjun Zhu M.M.University, hospital or other
- Collaborators
- Zhangjiagang First People's Hospital
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 14 Feb 2022 (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 objective is to investigate the efficacy and safety of Envafolimab combined with chemotherapy in the treatment of metastatic or recurrent gastric adenocarcinoma.
Detailed description
Envafolimab indication: Envafolimab is the world's first subcutaneous injection of PD-L1 monoclonal antibody.Suitable for adult patients with advanced solid tumors with unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects (dMMR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| envafolimab plus chemotherapy | Experimental | Drug: Envafolimab, Drug: Oxaliplatin, Drug: S1Envafolimab:300mg,sc,d1,Q3W; Chemotherapy:SOX(Oxaliplatin，130mg/m2, iv,d1,Q3W + S-1，40mg/m2, op,bid,d1-14,Q3W). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18-75 years；
- ECOG 0-1；
- life expectancy of at least 3 months；
- Negative for HER2 gene expression by central laboratory ；
- The tumor expresses PD-L1 as detected by the central laboratory, and the tumor proportion score (CPS) ≥ 1；
Key exclusion criteria (11 listed)
- Suffered from other malignant tumors within 5 years before the start of treatment in this study;
- Pathologically suggested patients with abnormally increased AFP OR MSI-H ；
- Grade ≥1 unresolved toxicities (according to the most recent version of the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]) due to any prior therapy, excluding alopecia and fatigue; neurotoxicity was Recovery to ≤ grade 1 or baseline before the group;
- Subjects with any severe and/or uncontrolled disease ；
- Poorly controlled diabetes (fasting blood glucose [FBG] > 10 mmol/L) ；
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 |
|---|---|---|
| EnvafolimabAlso: Immunotherapy300mg,sc,d1,Q3W | Drug | envafolimab plus chemotherapy |
| OxaliplatinAlso: Chemotherapy130mg/m2, iv,d1,Q3W | Drug | envafolimab plus chemotherapy |
| S1Also: Chemotherapy40mg/m2, op,bid,d1-14,Q3W | Drug | envafolimab plus chemotherapy |
Primary outcome
ORR
Time frame: 6 months
Objective response rate
6 secondary outcomes
PFS
Time frame: 6 months
OS
Time frame: 12 months
DCR
Time frame: 9 months
DOR
Time frame: 12 months
AEs
Time frame: 12 months
Qualify of Life
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Metastatic or Recurrent Gastric Adenocarcinoma
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
Not yet recruitingObservational study
Zanidatamab Outcomes and Lived Experiences in Advanced HER2+ GEA
Esophageal Cancer, GastroEsophageal Cancer
RecruitingPhase 2
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas
HER2-negative, Gastroesophageal Junction
RecruitingPhase 2
Assessing Iparomlimab and Tuvonralimab in Recurrent or Metastatic MSI-H/dMMR Gastric Cancer
Gastric / Gastroesophageal Junction Adenocarcinoma, MSI-H Cancer
Active, not recruitingPhase 2
Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer
Gastric Adenocarcinoma, Esophagus Adenocarcinoma
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.
Liangjun Zhu study chair
Jiangsu Cancer Institute & 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 Envafolimab, Oxaliplatin and S1 in people with Metastatic or Recurrent Gastric Adenocarcinoma, run by Liangjun Zhu M.M. 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 10 inclusion and 11 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 5 Jan 2024. 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 Liangjun Zhu (+8613905199123, zhulj98@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 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 5 Jan 2024.