AzTrials
AzTrials

Gastric/Gastroesophageal Junction AdenocarcinomaPhase 2NCT05387681

Preoperative Short Course Radiotherapy With Envafolimab, Endostatin and SOX Regimen in Locally Advanced Gastric

A Phase 2 study testing Envafolimab in people with Gastric/Gastroesophageal Junction Adenocarcinoma and Radiotherapy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

This is a single-arm, exploratory clinical study to evaluate the efficacy and safety of Preoperative short course radiotherapy with Envafolimab, Endostatin and SOX regimen in resectable locally advanced gastric/gastroesophageal junction adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Envafolimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
No sites listed yet
Study dates
30 May 2022to 30 Dec 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Signed written informed consent before enrollment; 2.18 years old ≤75 years old, male or female; 3. Initially diagnosed locally advanced gastric/gastroesophageal junction adenocarcinoma confirmed by tissue or pathology; 4. Without systemic treatment; 5. Patients diagnosed as CT2-4an + M0 according to endoscopic ultrasonography or enhanced CT/MRI scan cTNM were assessed by researchers as suitable for neoadjuvant therapy + radical surgery. AJCC/UICC Version 8 was used for TNM pathological staging (pTNM).
  • 6.ECOG PS score: 0 ~ 1; 7. The expected survival time is more than 6 months; 8. The function of vital organs meets the following requirements (excluding any blood components and cell growth factors within 14 days) :
  • Blood routine:
  • Neutrophils ≥1.5×109/L Platelet count ≥100×109/L Hemoglobin ≥ 90g/L;
  • Liver and kidney function:
  • Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal value (ULN) or creatinine clearance ≥50 mL /min (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 1.5 times normal upper limit (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤ 2.5 times the upper limit of normal value (ULN) (≤5ULN if abnormal liver function is due to liver metastasis); Urine protein \& lt; 2 +; If urine protein ≥2+, 24-hour urine protein quantification must be ≤1g; 9. Normal coagulation function, no active bleeding and thrombotic diseases
Show all 9Show fewer
  • International standardized ratio INR≤1.5×ULN;
  • Partial thrombin time APTT≤1.5×ULN;
  • Prothrombin time PT≤1.5×ULN; 10. Women of non-surgical sterilization or childbearing age are required to use a medically approved contraceptive method (such as an intrauterine device, birth control pill or condom) during the study period and for three months after the study period; The serum or urine HCG test of female patients of reproductive age who were not undergoing surgical sterilization must be negative within 7 days prior to study enrollment. And must be non lactation period; Male patients of non-surgical sterilization or reproductive age are required to consent with their spouse to use a medically approved contraceptive method during the study treatment period and for 3 months after the study treatment period 11. The subjects voluntarily participated in the study with good compliance and follow-up for safety and survival.

Who cannot join

  • The subject has previous or co-existing malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
  • Previous treatment with other PD-1/PD-L1 inhibitors could not be included; Subject is known to have a prior allergy to large protein preparations, or is known to be allergic to the drug ingredient used;
  • The subjects exist any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, the pituitary gland inflammation, vasculitis, nephritis, thyroid function hyperfunction, thyroid function is reduced, always had thyroid surgery must be incorporated into; Subjects with vitiligo or asthma in complete remission during childhood without any intervention as adults could be included; Subjects with asthma requiring medical intervention with bronchodilators were excluded);
  • Subject is receiving immunosuppressant, or systemic, or absorbable local hormone therapy for immunosuppression purposes (dose \> 10mg/ day of prednisone or other equivalent hormone) and continued to use within 2 weeks prior to enrollment;
  • Clinical ascites or pleural effusion requiring therapeutic puncture or drainage;
  • Patients with cardiac clinical symptoms or diseases that are not well controlled, such as :(1) nyha class 2 or more heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant ventricular or ventricular arrhythmias requiring treatment or intervention;
Show all 17Show fewer
  • Within 14 days before the first administration of the study drug, Chinese herbal medicines or proprietary Chinese medicines approved by the National Medical Products Administration of China (NMPA) with antitumor activity, regardless of cancer type;
  • Subject has active infection or unexplained fever during screening but prior to initial administration \& GT; 38.5 degrees (the investigator judged that the fever caused by the tumor could be included in the study);
  • Patients with past or present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-associated pneumonia, known active tuberculosis, severely impaired lung function, etc.;
  • Subjects with congenital or acquired immune deficiency (such as HIV infection, HIV 1/2 antibody positive);
  • Patients with acute or chronic active Hepatitis B (HBsAg or core antibody.HBcAb) should be tested for Hepatitis B virus (HBV)DNA, such as HBV DNA copy number ≤2×103 copy number/mL or ≤200 IU/ mL or lower than the detection limit can be included. HBsAg (+) subjects should receive anti-HBV therapy throughout study drug therapy to avoid viral activation. Subjects who are resistant to HBc(+), HBsAg(-), anti-HBS (-), and HBV viral load (-) do not need prophylactic anti-HBV therapy, but should be closely monitored for virus reactivation;
  • Acute or chronic active Hepatitis C Virus (HCV), that is, HCV antibody positive and HCV RNA levels above the detection limit;
  • Received live vaccine less than 4 weeks prior to study administration or possibly during the study period;
  • The subject has a known history of psychotropic drug abuse, alcoholism or drug abuse;
  • Known Her2 positive;
  • Prone to stomach bleeding; Patients with any evidence or history of bleeding; Patients with any bleeding or bleeding event ≥CTCAE grade 3 within 4 weeks prior to grouping had unhealed wounds, ulcers or fractures;
  • Researchers think that should be left out in this study, the researchers determine, for example, the subjects have other factors that may result in this study were forced to midway termination, such as, other serious disease (including mental illness) need to merge treatment, there are serious abnormal laboratory examination, accompanied by factors such as family or society, will affect the safety of the subjects, or information and the collection of the sample.

Trial locations and contacts

No sites are listed yet.

dan dan Yu contact

027-85871982

yudandan@hust.edu.cn

About this study

Official title: An Exploratory Clinical Study of Short-course Radiotherapy Combined With Envafolimab, Endostatin and SOX Regimen for Neoadjuvant Treatment of Resectable Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

This is a single-arm, exploratory clinical study to evaluate the efficacy and safety of Preoperative short course radiotherapy with Envafolimab, Endostatin and SOX regimen in resectable locally advanced gastric/gastroesophageal junction adenocarcinoma.

Read the detailed description

All eligible subjects will receive 5*5Gy (25Gy/5F) fractionated radiotherapy, rest for 1 week, 3 cycles of Envafolimab, Endostatin and SOX regimen, and radical surgery 2 to 4 weeks after completion of the last neoadjuvant therapy, according to the study plan. Each patient will be followed up 12 months after initiation of treatment in the study. Whether the subjects need adjuvant therapy after surgery and the adjuvant treatment plan are determined by the investigator. All subjects were required to complete the study follow-up plan after surgery.

Being tested
Envafolimab
Keywords
neoadjuvant，gastric

What participants receive

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

  • EnvafolimabDrug

    Also called Endostatin

    short course radiotherapy ：5*5Gy (25Gy/5F) ； Envafolimab：300 mg, subcutaneously, D1, Q3W; Endostatin ：210mg (14 doses), CIV continuously pumped for 72h, Q3W; chemotherapy：SOX regimen

Study groups in NCT05387681
Study groupRoleWhat they receive
Envafolimab, Endostatin and SOX regimenExperimentalPreoperative short course radiotherapy with Envafolimab, Endostatin and SOX regimen
Receives: Drug: Envafolimab

What is being measured

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

  1. pathological complete response (pCR)

    Pathological complete response (pCR) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0/Tis ypN0 in the current AJCC staging system)

    Measured: one year

Secondary outcomes (2)

  1. R0 resection rates

    R0 resection was performed if there was no visible tumor residue within 1 mm of the surgical margin.

    Measured: one year

  2. pathological partial response(MPR)

    It was defined as ≤ 10% remaining viable tumor cells at surgical resection of the primary tumor

    Measured: one year

Timeline

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

  1. First posted24 May 2022
  2. Study start30 May 2022 (estimated)
  3. Primary completion30 Jul 2023 (estimated)
  4. Study completion30 Dec 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05387681
Sponsor's protocol ID
SMA-GC-003V
Status last verified
May 2022
First submitted
12 May 2022
Last updated
24 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li J, Deng Y, Zhang W, Zhou AP, Guo W, Yang J, Yuan Y, Zhu L, Qin S, Xiang S, Lu H, Gong J, Xu T, Liu D, Shen L. Subcutaneous envafolimab monotherapy in patients with advanced defective mismatch repair/microsatellite instability high solid tumors. J Hematol Oncol. 2021 Jun 21;14(1):95. doi: 10.1186/s13045-021-01095-1.

    PubMed 34154614

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Envafolimab in people with Gastric/Gastroesophageal Junction Adenocarcinoma and Radiotherapy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

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 17 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 May 2022. Status can change between updates, so confirm with the study contact before making plans.

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 dan dan Yu (027-85871982, yudandan@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pathological complete response (pCR) (time frame: one year). 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 NCT05387681, which also lists 1 linked publication.

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 May 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in