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

NCT06599775 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-EC-II-018
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Resectable Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (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

  14 days after endoscopic resection

Secondary Outcomes (5)

• Major pathological response

  14 days after endoscopic resection

• Overall Survival

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

• Recurrence free survival

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

• Incidence of Adverse events

  through study completion, assessed up to 50 months

• Patients' quality of life

  through study completion, assessed up to 50 months

Study Arms (1)

Adebrelimab and chemotherapy combined with endoscopic resection and simultaneous chemoradiotherapy

EXPERIMENTAL

Adebelizumab, an innovative PD-L1 inhibitor, combined with chemotherapy followed by endoscopic resection and subsequent concurrent chemoradiotherapy

Drug: Adebrelimab injection; Drug: Albumin-Bound Paclitaxel; Drug: Carboplatin injection

Interventions

Adebrelimab injection DRUG

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

Also known as: SHR-1316

Adebrelimab and chemotherapy combined with endoscopic resection and simultaneous chemoradiotherapy

Albumin-Bound Paclitaxel DRUG

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

Also known as: Albumin-Bound Paclitaxel injection

Adebrelimab and chemotherapy combined with endoscopic resection and simultaneous chemoradiotherapy

Carboplatin injection DRUG

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

Also known as: Carboplatin for injection

Adebrelimab and chemotherapy combined with endoscopic resection and simultaneous chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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:
• Have a clinical cardiac condition or disease that is not well controlled, such as:
• 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.
• \. 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.
• \. Presence of allergies and adverse drug events: Presence of allergy or hypersensitivity to monoclonal antibodies Presence of allergic reaction to albumin-bound paclitaxel, carboplatin
• \. 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Interventions

Albumin-Bound Paclitaxel; Carboplatin; Injections

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09