Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab injection | Drug | Experimental group:Adebrelimab is an innovative PD-L1 inhibitor, monotherapy can improve pathological complete response rates with tolerable safety |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response | defined as the percentage of subjects with <10% residual tumor in the primary tumor site | 14 days after endoscopic resection |
| Overall Survival | Overall Survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
|
|
| 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 |
|
|
| 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 | Recurrence free survival | From the time of complete response to the date of recurrence,assessed up to 100 months |
| Incidence of Adverse events | Incidence of Adverse events | through study completion, assessed up to 50 months |
| 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) | through study completion, assessed up to 50 months |
| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| D016190 | Carboplatin |
| D007267 | Injections |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D056831 | Coordination Complexes |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided