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Gastric / Gastroesophageal Junction AdenocarcinomaPhase 2NCT06030934

Study of The Second-line Treatment of Advanced Gastric / Gastroesophageal Junction Adenocarcinoma With Envafolimab and Lenvatinib Combined With Paclitaxel-albumin

A Phase 2 study testing envafolimab and lenvatinib combined with paclitaxel-albumin in people with Gastric / Gastroesophageal Junction Adenocarcinoma, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is an open, exploratory clinical study. Eligible patients with advanced second-line gastric/gastroesophageal junction adenocarcinoma signed an informed consent form, were screened for enrollment, and were entered into Group A (non-immune retreatment group-patients who had failed previous first-line… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
envafolimab and lenvatinib combined with paclitaxel-albumin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
24 Oct 2022to 1 Sep 2025
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent prior to enrollment.
  • Age 18-80 years.
  • Negative for HER2
  • Diagnosis confirmed by histological examination and/or cytological examination combined with imaging assessment of advanced metastatic gastric/gastroesophageal junction adenocarcinoma.
  • Failure of previous first-line therapy. Group A (non-immune retreatment): patients who have failed prior chemotherapy with first-line standard therapy. Group B (immune retreatment): patients who received previous first-line PD-1 antibody therapy with optimal efficacy SD and on.
  • ECOG score: 0 to 1.
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  • At least one measurable lesion (≥10 mm long diameter on CT scan for non-lymph node lesions and ≥15 mm short diameter on CT scan for lymph node lesions according to iRECIST criteria).
  • Adequate organ function with.
  • Routine blood: Absolute Neutrophil Count (ANC) 1.5 × 109/L, Platelets (Platelet, PLT) ≥ 70 × 109/L, Hemoglobin (HGB) ≥ 90 g/L.
  • Liver function: Total Bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤3×ULN; serum albumin ≥28 g/L; Alkaline Phosphatase (ALP) ≤5×ULN; after conventional hepatoprotective treatment meeting the above criteria, and can be stable for at least 1 week after evaluation by the investigator can be enrolled.
  • Renal function: Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/mi (applying the standard Cockcroft-Gault formula).
  • Coagulation function: International Normalized Ratio (INR) ≤ 1.5 /PT ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN; if the subject is receiving anticoagulation therapy, as long as PT and INR are within the range drawn up by anticoagulant drugs.
  • A predicted survival of ≥ 3 months.
  • Female patients must be non-pregnant and non-lactating and are required to use a medically approved form of contraception (e.g., IUD, pill or condom) during study treatment and for at least 120 days after study completion, and are not allowed to donate eggs to another person or freeze them for fertilization and propagation during this period.

Who cannot join

  • Symptomatic brain metastases.
  • Known MSI-H/dMMR.
  • A prior history of a primary tumor outside of the gastric/gastroesophageal junction
  • Active autoimmune disease or autoimmune disease with potential for recurrence such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, previous thyroid surgery cannot be included; subjects with vitiligo or complete remission of asthma in childhood and adult who do not require any intervention afterwards can be included; subjects with asthma requiring medical intervention with bronchodilators cannot be included.
  • Subjects with any severe and/or uncontrolled disease. including.
  • Poorly controlled blood pressure (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting blood glucose [FBG] > 10 mmol/L)
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  • Having ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470ms) and ≥ grade 2 congestive heart failure (New York Heart Association [NYHA] classification)
  • Active or uncontrolled severe infection (≥ CTCAE grade 2 infection) requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection
  • Active hepatitis (transaminases do not meet the inclusion criteria, hepatitis B reference: HBV DNA ≥ 2000 IU/ml or ≥ 104 copies/ml; hepatitis C reference: HCV RNA ≥ 2000 IU/ml or ≥ 104 copies/ml; after nucleotide based antiviral therapy below the above criteria, can be enrolled); chronic hepatitis B virus carriers with HBV DNA < 104 IU/ml, who must receive concomitant antiviral therapy during the trial to be enrolled.
  • Those with renal failure requiring hemodialysis or peritoneal dialysis.
  • Those with a history of immunodeficiency, including HIV-positive or suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation
  • Active autoimmune disease requiring systemic therapy (e.g., use of disease-relieving drugs, corticosteroids, or immunosuppressive agents) within 2 years prior to the start of study treatment, except for replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency); receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy. Doses >10 mg/day of prednisone or other equivalent hormone and within 2 weeks of the first dose and still continuing
  • Those with a history of active tuberculosis
  • Those who fail to control and still require repeated drainage of ascites, pericardial effusion, pleural effusion.
  • Research treatment related to.
  • Patients who have undergone major organ transplantation
  • Those who have undergone major surgical treatment, incisional biopsy or significant traumatic injury within 28 days prior to the start of study treatment; or have a long-standing untreated wound or fracture
  • History of live attenuated vaccination within 14 days prior to the start of study treatment or planned live attenuated vaccination during the study
  • History of severe hypersensitivity reactions following the use of monoclonal antibodies; known hypersensitivity to active ingredients or excipients such as envafolimab, lenvatinib, etc., of this study drug
  • Those who are participating or have participated in other clinical studies within 4 weeks prior to the start of the study
  • Those with a history of severe allergy.
  • Women who are pregnant or breastfeeding
  • At risk for bleeding, or with coagulation disorders, or undergoing thrombolytic therapy
  • Those with a history of psychotropic substance abuse and unable to abstain or with psychiatric disorders
  • Subjects who, in the judgment of the investigator, have a concomitant disease that seriously jeopardizes the safety of the subject or interferes with the completion of the study, or subjects for whom other reasons are deemed to exist that make them unsuitable for enrollment In the judgment of the investigator, subjects who, in the judgment of the investigator, have a concomitant disease that seriously jeopardizes the safety of the subject or interferes with the completion of the study, or subjects for whom other reasons are deemed to exist that make them unsuitable for enrollment

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: An Open and Exploratory Study of The Second-line Treatment of Advanced Gastric / Gastroesophageal Junction Adenocarcinoma With Envafolimab and Lenvatinib Combined With Paclitaxel-albumin

This study is an open, exploratory clinical study. Eligible patients with advanced second-line gastric/gastroesophageal junction adenocarcinoma signed an informed consent form, were screened for enrollment, and were entered into Group A (non-immune retreatment group-patients who had failed previous first-line treatment with standard chemotherapy) and Group B (immune retreatment-patients who had obtained SD and above with best efficacy of previous first-line treatment with PD-1 antibody) based on whether they had received previous first-line treatment with PD-1 antibody. All patients received a combination of envafolimab and lenvatinib in combination with paclitaxel-albumin and were treated until disease progression, withdrawal of informed consent by the subject, loss to follow-up, and death, where treatment did not exceed 2 years. Clinical oncologic imaging assessments were performed using iRECIST every 8 weeks during treatment; safety assessments were performed using CTCAE 5.0, and adverse events were recorded throughout the study up to 30 days after the end of treatment.

Being tested
envafolimab and lenvatinib combined with paclitaxel-albumin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • envafolimab and lenvatinib combined with paclitaxel-albuminDrug

    envafolimab: 200mg d1,15 s.c. Q4W; lenvatinib: 8mg (<60kg) or 12mg (≥60kg) p.o. Q.d.; paclitaxel-albumin: 100 mg/m2 d1,8,15 stop for one week, i.v. Q4W

Study groups in NCT06030934
Study groupRoleWhat they receive
Patients who have failed previous standard chemotherapyExperimentalNot described
Receives: Drug: envafolimab and lenvatinib combined with paclitaxel-albumin
Patients with SD or above obtained by previous first-line PD-1 antibody therapyExperimentalNot described
Receives: Drug: envafolimab and lenvatinib combined with paclitaxel-albumin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants with measurable lesions achieving a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria.

    Measured: 12 months

Secondary outcomes (5)

  1. Progression-free Survival (PFS)

    Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.

    Measured: 12 months

  2. Disease Control Rate (DCR)

    The proportion of participants who achieves a best overall response of CR, PR or stable disease(SD).

    Measured: 12 months

  3. Duration of Response (DoR)

    The time from the date that response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever occurs first.

    Measured: 12 months

  4. Overall Survival (OS)

    OS is defined as the time from enrollment to death from any cause.

    Measured: 20 months

  5. Adverse Events (AEs)

    Adverse Events (AEs) according to CTCAE v5.0

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2023
  2. Study start24 Oct 2022
  3. Primary completion1 Nov 2024 (estimated)
  4. Study completion1 Sep 2025 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06030934
Sponsor's protocol ID
SMA-GC-002
Status last verified
Sep 2023
First submitted
3 Sep 2023
Last updated
11 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing envafolimab and lenvatinib combined with paclitaxel-albumin in people with Gastric / Gastroesophageal Junction Adenocarcinoma, run by Fudan 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 14 inclusion and 25 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 Sep 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06030934.

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 Sep 2023.

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