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Esophageal Squamous Cell CarcinomaPhase 2NCT05552651

Envafolimab Combined With Chemotherapy in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Envafolimab, Albumin-Bound Paclitaxel and Carboplatin in people with Esophageal Squamous Cell Carcinoma, run by Tao Jiang.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The objective is to investigate the efficacy and safety of envafolimab combined with chemotherapy for preoperative neoadjuvant therapy in patients with resectable esophageal squamous cell carcinoma Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Envafolimab, Albumin-Bound Paclitaxel and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
20 Sep 2022to 20 Dec 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

  • The subjects voluntarily joined the study, signed the informed consent form, and had good compliance;
  • 18-75 years；
  • ECOG 0-1；
  • life expectancy of at least 3 months；
  • For patients diagnosed with thoracic esophageal squamous cell carcinoma by histopathological examination of the primary tumor, the stage of esophageal cancer was clearly diagnosed as cT1b-cT2 N+ or cT3-cT4a anyN stage by CT or MRI or color Doppler ultrasound or PET-CT or ultrasonography before surgery , and evaluated by the investigator as suitable for patients treated with this study protocol.
  • Not received any anti-tumor therapy in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc. However, exploratory thoracotomy, mediastinoscopy, excisional biopsy or similar surgical procedures for definite diagnosis, staging and surgical treatment of esophageal cancer can be accepted.
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  • 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;
  • The doctor's clinical judgment has sufficient organ function;
  • 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;
  • Patients with tumor invading the cervical esophagus or high upper thoracic segment requiring a laryngectomy;
  • Patients with a high risk of bleeding or perforation due to the obvious invasion of the tumor into the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have already formed a fistula;
  • Subjects with any severe and/or uncontrolled disease;
  • Poor blood pressure control (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg);
  • Subjects with any severe and/or uncontrolled disease ；
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  • Have clinical symptoms or diseases of the heart that are not well controlled；
  • Patients with past and current objective evidence of history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired lung function；
  • Acute or chronic active hepatitis B (hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive patients need to be tested for hepatitis B virus (HBV) DNA, such as HBV DNA copy number ≤2×103 copies/ml or ≤200 IU/ml or below the lower limit of detection, can be enrolled. HBsAg (+) subjects should receive anti-HBV therapy throughout the study drug treatment period to avoid viral activation. For anti-HBV Subjects with HBc(+), HBsAg(-), anti-HBs(-) and HBV viral load(-) do not need to receive preventive anti-HBV treatment, but need to be closely monitored for virus reactivation;
  • A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  • Poor control of diabetes (fasting blood glucose [FBG]> 10mmol/L);
  • Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;
  • Those who have received major surgical treatment, incision biopsy or obvious traumatic injury within 28 days before the start of study treatment; or have long-term unhealed wounds or fractures;
  • Serious arterial/venous thrombotic events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, occurred within 6 months before the start of study treatment;
  • Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders;
  • Patients who have received tumor treatment in the past;
  • Subjects with uncontrolled pleural effusion, pericardial effusion or ascites (judgment by the investigator) who still need repeated drainage;
  • Subjects with known central nervous system metastases and/or cancerous meningitis;
  • History of vaccination with live attenuated vaccine within 14 days before the start of study treatment or planned vaccination with live attenuated vaccine during the study period;
  • Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids or immunosuppressants) within 2 years before the start of study treatment, alternative therapy (such as thyroxine, insulin, or adrenal or pituitary use) Physiological corticosteroids with insufficiency, etc.) are excluded;
  • Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy. (dose>10mg/day prednisone or other equivalent therapeutic hormones), and continued use within 2 weeks of the first administration;
  • Those with a history of active tuberculosis;
  • Within 4 weeks before the start of the study, are participating in or have participated in other clinical investigators;
  • Those who have been treated with other PD-1/PD-L1 inhibitors in the past cannot be enrolled; the subjects are known to be allergic to macromolecular protein preparations, or known to be allergic to the applied drug components;
  • Those who are known to be allergic to the active ingredients or excipients of the study drugs such as envolimab, nab-paclitaxel, and nedaplatin;
  • According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered unsuitable for enrollment for other reasons.

Trial locations and contacts

No sites are listed yet.

Tao Jiang contact

13991230762

2585408668@qq.com

shi cao li contact

029-84717761

tangduec@126.com

About this study

Official title: A Single-arm, Exploratory Clinical Study of Envafolimab Combined With Chemotherapy in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma

The objective is to investigate the efficacy and safety of envafolimab combined with chemotherapy for preoperative neoadjuvant therapy in patients with resectable esophageal squamous cell carcinoma

Read the detailed description

This study is a single-arm, exploratory phase II clinical study. In the study, all patients with esophageal squamous cell carcinoma who meet the inclusion criteria will receive 3 cycles (21 days of 1 cycle) of neoadjuvant envolizumab combined with chemotherapy Treatment, radical surgery 4-6 weeks after completion of the last neoadjuvant therapy.

Being tested
Envafolimab, Albumin-Bound Paclitaxel, Carboplatin
Keywords
neoadjuvant therapy
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • EnvafolimabDrug

    300mg,sc,d1,Q3W;

  • Albumin-Bound PaclitaxelDrug

    130mg/m2,iv,D1,D8,Q3W

  • CarboplatinDrug

    AUC=5, iv,D1,Q3W

Study groups in NCT05552651
Study groupRoleWhat they receive
Envafolimab plus chemotherapyExperimentalNot described
Receives: Drug: Envafolimab; Drug: Albumin-Bound Paclitaxel; Drug: Carboplatin

What is being measured

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

  1. Rate of pCR

    Rate of pathological complete remission

    Measured: From Baseline to primary completion date, about 6 months

Secondary outcomes (1)

  1. Rate of MPR

    Rate of major pathological remission

    Measured: From Baseline to primary completion date, about 6 months

Timeline

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

  1. First posted23 Sep 2022
  2. Study start20 Sep 2022 (estimated)
  3. Primary completion20 Dec 2023 (estimated)
  4. Study completion20 Dec 2023 (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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05552651
Sponsor's protocol ID
202208-20
Status last verified
Sep 2022
First submitted
14 Sep 2022
Last updated
23 Sep 2022
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, Albumin-Bound Paclitaxel and Carboplatin in people with Esophageal Squamous Cell Carcinoma, run by Tao Jiang.

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 26 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 23 Sep 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 Tao Jiang (13991230762, 2585408668@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of pCR (time frame: From Baseline to primary completion date, about 6 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 NCT05552651.

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 23 Sep 2022.

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