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Resectable Esophageal Squamous Cell CarcinomaPhase 2NCT06599775

Study of Adebrelimab With Chemotherapy, Endoscopy and Sequential Chemoradiotherapy In Inoperable Esophageal Cancer

A Phase 2 study testing Adebrelimab injection, Albumin-Bound Paclitaxel and Carboplatin injection in people with Resectable Esophageal Squamous Cell Carcinoma, run by Shanghai Zhongshan Hospital.

Not yet recruiting

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

Official record
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Trial summary

Evaluating the efficacy and safety of PD-L1 (Programmed Death-L1)antibody combined with endoscopy and radiotherapy for inoperable cT1b-2 (clinical stage tumor 1b-2) esophageal squamous cell carcinoma Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Adebrelimab injection, Albumin-Bound Paclitaxel and Carboplatin injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
No sites listed yet
Study dates
Oct 2024to Oct 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

  • Signed written informed consent to voluntarily enroll in the study
  • Age 18-75 years
  • Histologically or cytologically confirmed squamous esophageal cancer of the thoracic segment
  • Staging of clinical tumor stage T1b-2N0M0 (according to American Joint Committee on Cancer 8th edition) as judged by the investigator
  • Contraindication to or refusal of oesophagectomy
  • No prior treatment for oesophageal cancer, including radiotherapy, chemotherapy, or surgery
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  • Have at least one measurable lesion (RECIST 1.1 criteria)
  • Eastern Cooperative Oncology Group Performance Status score of 0 to 1
  • No contraindication to radiotherapy
  • Adequate organ function on laboratory tests within 14 days prior to the first administration of the drug Blood routine: WBC≥3.0×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HGB≥90 g/L Liver function: AST≤2.5×ULN; ALT≤2.5×ULN; TBIL≤1.5×ULN Renal function: Cr≤1.5×ULN or creatinine clearance rate ≥50 mL/min Coagulation function: International Normalized Ratio ≤1.5, activated partial thromboplastin time ≤1.5×ULN
  • Female subjects of childbearing potential must have a negative blood pregnancy test performed within 72 hours prior to the first dose and not be breastfeeding, and must agree to use effective contraception for the duration of the trial and for 2 months after the last administration of adebrelimab or 6 months after the last administration of chemotherapeutic agent, whichever is longer; for female subjects whose partner is a female of childbearing potential Male subjects should be surgically sterilised or agree to use effective contraception for the duration of the trial and for 2 months after the last administration of adebrelimab or 3 months after the last administration of chemotherapeutic agent, whichever is longer; sperm donation is not permitted during the study.

Who cannot join

  • Criteria related to treatment history:
  • Any treatment for oesophageal cancer, including surgery, radiotherapy, chemotherapy or other antineoplastic agents Ongoing treatment with immunosuppressive drugs, or systemic hormonal drugs for immunosuppression (doses >10 mg/day prednisone or equivalent) within 2 weeks prior to the first use of study drug; inhaled or topical steroids and adrenal glands at doses >10 mg/day prednisone or equivalent are permitted in the absence of active autoimmune disease Corticosteroid replacement Received live attenuated vaccine within 4 weeks prior to first use of study drug Major surgery or severe trauma within 4 weeks prior to first use of study drug.
  • Tumour-related criteria Patients with non-squamous oesophageal cancer Staging not consistent with clinical tumor stage T1b~2N0M0 Other malignancies diagnosed within 5 years prior to first use of study drug, except cured carcinoma in situ of the uterine cervix, basal or squamous cell skin cancers, limited prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery
  • Other criteria:
  • Presence of any active autoimmune disease or history of autoimmune disease (the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma that has been in complete remission in childhood and does not require any intervention in adulthood are eligible for inclusion; (Subjects with asthma requiring medical intervention with bronchodilators are not eligible for inclusion)
  • Have a clinical cardiac condition or disease that is not well controlled, such as:
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  • New York Heart Association class 2 or higher heart failure;
  • unstable angina pectoris;
  • myocardial infarction within 1 year;
  • clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention Pregnant or breastfeeding women.
  • 4. Laboratory Tests: Subjects serologically positive for HIV Active hepatitis B (HbsAg positive and hepatitis B virus DNA ≥2000 IU/ml or copy number ≥104/ml) or active hepatitis C (HCV antibody positive and HCV-RNA positive with concomitant need for antiviral therapy) Active tuberculosis.
  • 5. Presence of allergies and adverse drug events: Presence of allergy or hypersensitivity to monoclonal antibodies Presence of allergic reaction to albumin-bound paclitaxel, carboplatin
  • 6. Diseases or laboratory abnormalities that, in the opinion of the investigator, may affect the results of the study or are not in the interest of the subject.

About this study

Official title: Prospective, Single-arm, Multicenter Exploratory Study of Adebrelimab Combined With Chemotherapy, Endoscopic Resection and Sequential Chemoradiotherapy In the Treatment of Inoperable Clinical Staging T1b-2 Esophageal Squamous Cell Carcinoma

Evaluating the efficacy and safety of PD-L1 (Programmed Death-L1)antibody combined with endoscopy and radiotherapy for inoperable cT1b-2 (clinical stage tumor 1b-2) esophageal squamous cell carcinoma

Read the detailed description

Previous studies have already confirm immunotherapy combine with chemotherapy can improve pathological complete response rates. Therefore, it is proposed to carry out a study of immuno-combination chemotherapy combined with endoscopic resection and synchronous radiotherapy and chemotherapy in patients with clinical stage cT1-2N0M0 (clinical stage tumor 1b-2 clinical stage nodes 0 stage metastasis 0) to evaluate the efficacy and safety

Being tested
Adebrelimab injection, Albumin-Bound Paclitaxel, Carboplatin injection

What participants receive

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

  • Adebrelimab injectionDrug

    Also called SHR-1316

    Experimental group：Adebrelimab is an innovative PD-L1 inhibitor, monotherapy can improve pathological complete response rates with tolerable safety

  • Albumin-Bound PaclitaxelDrug

    Also called Albumin-Bound Paclitaxel injection

    Experimental group：combined with Adebrelimab（PD-L1 inhibitor）,and carboplatin followed by endoscopic resection and subsequent simultaneous radiotherapy combined with albumin-bound paclitaxel and carboplatin

  • Carboplatin injectionDrug

    Also called Carboplatin for injection

    Experimental group：combined with Adebrelimab（PD-L1 inhibitor），and albumin-bound paclitaxel followed by endoscopic resection and subsequent simultaneous radiotherapy combined with albumin-bound paclitaxel and carboplatin

Study groups in NCT06599775
Study groupRoleWhat they receive
Adebrelimab and chemotherapy combined with endoscopic resection and simultaneous chemoradiotherapyExperimentalAdebelizumab, an innovative PD-L1 inhibitor, combined with chemotherapy followed by endoscopic resection and subsequent concurrent chemoradiotherapy
Receives: Drug: Adebrelimab injection; Drug: Albumin-Bound Paclitaxel; Drug: Carboplatin injection

What is being measured

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

  1. Pathological complete response of primary lesion

    defined as the proportion of subjects with no residual tumor in the primary tumor site and histologically negative lymph nodes

    Measured: 14 days after endoscopic resection

Secondary outcomes (5)

  1. Major pathological response

    defined as the percentage of subjects with <10% residual tumor in the primary tumor site

    Measured: 14 days after endoscopic resection

  2. Overall Survival

    Overall Survival

    Measured: From date of signed informed consent until the date of death from any cause, whichever came first, assessed up to 100 months

  3. Recurrence free survival

    Recurrence free survival

    Measured: From the time of complete response to the date of recurrence，assessed up to 100 months

  4. Incidence of Adverse events

    Incidence of Adverse events

    Measured: through study completion, assessed up to 50 months

  5. Patients' quality of life

    Assessment of patients' quality of life by means of quality of life score questionnaires, such as EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30)

    Measured: through study completion, assessed up to 50 months

Timeline

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

  1. First posted19 Sep 2024
  2. Study startOct 2024 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 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
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06599775
Sponsor's protocol ID
MA-EC-II-018
Status last verified
Sep 2024
First submitted
26 Jul 2024
Last updated
19 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adebrelimab injection, Albumin-Bound Paclitaxel and Carboplatin injection in people with Resectable Esophageal Squamous Cell Carcinoma, run by Shanghai Zhongshan Hospital.

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 11 inclusion and 13 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 19 Sep 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?

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?

Pathological complete response of primary lesion (time frame: 14 days after endoscopic resection). 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 NCT06599775.

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 19 Sep 2024.

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