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

ConditionResectable Esophageal Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

New York Heart Association class 2 or higher heart failure;

unstable angina pectoris;

myocardial infarction within 1 year;

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab injection

    Drug

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

  • 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

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: Adebrelimab and chemotherapy combined with endoscopic resection and simultaneous chemoradiotherapyExperimental treatment 3 interventions

Trial outcomes

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

Time frame
14 days after endoscopic resection

Secondary outcomes

1

Major pathological response

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

Time frame
14 days after endoscopic resection
2

Overall Survival

Overall Survival

Time frame
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

Time frame
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

Time frame
through study completion, assessed up to 50 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: