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Esophageal Squamous Cell CarcinomaPhase 2NCT06508229

Adebrelimab Combined With Albumin Paclitaxel and Nedaplatin as Neoadjuvant Therapy for Locally Advanced Resectable ESCC

A Phase 2 study testing Adebrelimab, albumin paclitaxel and Nedaplatin in people with Esophageal Squamous Cell Carcinoma, run by Harbin Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multi-center, single-arm, phase II clinical study designed to observe and evaluate the effectiveness and safety of adebrelimab combined with albumin paclitaxel and nedaplatin as neoadjuvant therapy for locally advanced 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?
Adebrelimab, albumin paclitaxel and Nedaplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
No sites listed yet
Study dates
30 Jul 2024to 30 May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Age: 18 to 75 years old, no limit to male or female;
  • Surgically resectable locally advanced esophageal squamous cell carcinoma confirmed by histology or cytology (clinical stage: stage IIa-IIIb);
  • Have measurable lesions and meet RECIST v1.1) standards;
  • Have not received any anti-tumor systemic treatment for esophageal cancer in the past;
  • ECOG PS: 0-1 points;
  • Expected survival ≥12 weeks;
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  • The functions of vital organs meet the following requirements:
  • Routine blood examination (no blood transfusion within 14 days, no correction with hematopoietic stimulating factor drugs):Hemoglobin (Hb) ≥90 g/L; absolute neutrophil count (ANC) ≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell count (WBC) ≥3.0×109/L;
  • Biochemical examination: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; serum total bilirubin (TBIL) ≤1.5×ULN (Gilbert syndrome subjects, ≤ 3×ULN); serum creatinine (Cr) ≤1.5 ×ULN or creatinine clearance ≥50ml/min;
  • Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤1.5×ULN;
  • Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥50%;
  • Non-surgical sterilization or female patients of childbearing age need to use a medically approved contraceptive method during the study treatment period and within 3 months after the end of the study treatment period; female patients of childbearing age who have non-surgical sterilization must use a medically approved contraceptive method before study enrollment. The serum or urine HCG test must be negative within 72 hours; and must be non-lactating; for males, they should be surgically sterilized, or agree to use appropriate contraceptive methods during the trial and within 3 months after the last administration of the trial drug;
  • The patient voluntarily joined this study, signed the informed consent form (ICF), had good compliance, and cooperated with the follow-up.

Who cannot join

  • Patients with locked lymph node metastasis;
  • Have a history of other malignant tumors in the past 5 years, except for cervical carcinoma in situ or cutaneous squamous cell carcinoma that has been fully treated, or basal cell carcinoma of the skin that has been basically controlled;
  • Suffering from bleeding disorders or a history of bleeding disorders;
  • Have undergone major surgery or serious trauma within 4 weeks before taking the study drug for the first time;
  • Those with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction;
  • Have a history of interstitial lung disease and non-infectious pneumonia;
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  • Suffering from active autoimmune diseases or a history of autoimmune diseases, such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or reduced thyroid function after thyroid hormone replacement therapy can be included;
  • Have a history of immunodeficiency, including testing positive for HIV, suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation;
  • Subjects have cardiovascular clinical symptoms or diseases that cannot be well controlled, including but not limited to:
  • 1) NYHA class II or above heart failure; 2) Unstable angina; 3) Myocardial infarction within 1 year; 4) Clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; 10. Severe active infection requiring intravenous antibiotic treatment occurs within 4 weeks before using the study drug; 11. Those who are allergic to experimental drugs; 12. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up visits; 13. Those who the researcher believes are not suitable to participate in this trial.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jianqun Ma, MD contact

+86-13359990466

jianqunma@aliyun.com

About this study

Official title: Adebrelimab Combined With Albumin Paclitaxel and Nedaplatin as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma：a Prospective, Single Arm, Phase 2 Clinical Study

This is a multi-center, single-arm, phase II clinical study designed to observe and evaluate the effectiveness and safety of adebrelimab combined with albumin paclitaxel and nedaplatin as neoadjuvant therapy for locally advanced resectable esophageal squamous cell carcinoma.

Read the detailed description

This study plans to include 65 patients who received 3 cycles of neoadjuvant therapy (Adebrelimab + albumin paclitaxel + nedaplatin) , and underwent surgery after the treatment was completed. The purpose of this study is to explore and evaluate the effectiveness and safety of adebrelimab combined with albumin paclitaxel and nedaplatin as neoadjuvant therapy for locally advanced resectable esophageal squamous cell carcinoma.

Being tested
Adebrelimab, albumin paclitaxel, Nedaplatin
Keywords
Adebrelimab, Chemotherapy, locally advanced ESCC
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.

  • AdebrelimabDrug

    Also called SHR-1316

    adebrelimab, IV

  • albumin paclitaxelDrug

    Also called Injectable paclitaxel (albumin bound)

    albumin paclitaxel, iv

  • NedaplatinDrug

    Also called Nedaplatin for injection

    Nedaplatin，IV

Study groups in NCT06508229
Study groupRoleWhat they receive
Immuno-chemotherapy for locally advanced ESCCExperimentalAdebrelimab + albumin paclitaxel + nedaplatin
Receives: Drug: Adebrelimab; Drug: albumin paclitaxel; Drug: Nedaplatin

What is being measured

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

  1. pathological complete remission rate

    After neoadjuvant therapy and surgery, there were no residual surviving tumor cells in the tumor bed in the postoperative specimens (% RVT=0)

    Measured: up to 24 months

Secondary outcomes (9)

  1. R0 resection rate

    The tumor lesion was completely removed, and no residual cancer cells were found on the cutting edge under the microscope

    Measured: up to 24 months

  2. Main pathological remission

    After neoadjuvant therapy and surgery, the proportion of tumor cells remaining alive in the tumor bed in the postoperative specimen is less than or equal to 10% (% RVT ≤ 10)

    Measured: up to 24 months

  3. objective response rate

    The proportion of patients whose tumors have shrunk to a certain amount and remained in remission for a certain period of time, including complete response (CR) and partial response (PR).

    Measured: up to 24 months

  4. Disease-free survival

    It was calculated from the time of first administration of study drug until disease progression or death.

    Measured: up to 24 months

  5. overall survival

    The time is calculated from the first administration of the study drug until death due to any cause (patients who were lost to follow-up are the last follow-up time; patients who are still alive at the end of the study are the end of follow-up date).

    Measured: up to 24 months

  6. Number of participants with treatment related adverse events asassessed by CTCAE v5.0

    Proportion of patients with treatment-related adverse events recorded using CTCAE 5.0 criteria

    Measured: up to 24 months

  7. Changes in the patient's mood

    Use PHQ-9 and GAD-7 to record the changes in patients' emotions during treatment

    Measured: up to 24 months

  8. The patient's nutritional status

    Use PNI, CNI and mCONUT scoring standards to record changes in the patient's nutritional status during treatment

    Measured: up to 24 months

  9. The pain level of patients

    NRS and VAS pain rating scales were used to assess changes in patients' pain levels during treatment.

    Measured: up to 24 months

Timeline

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

  1. First posted18 Jul 2024
  2. Study start30 Jul 2024 (estimated)
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 May 2028 (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
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06508229
Sponsor's protocol ID
SHR-1316-HLJ-005
Status last verified
Jul 2024
First submitted
27 May 2024
Last updated
18 Jul 2024
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 Adebrelimab, albumin paclitaxel and Nedaplatin in people with Esophageal Squamous Cell Carcinoma, run by Harbin Medical University.

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 13 inclusion and 10 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: opening soon, as of the sponsor's last update on 18 Jul 2024. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jianqun Ma, MD (+86-13359990466, jianqunma@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pathological complete remission rate (time frame: up to 24 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 NCT06508229.

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 18 Jul 2024.

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