NeoAdjuvant Therapy With Immunoreagent (SHR-1316) for Resectable Oesophageal Squamous Cell carciNoma

NCT04215471 | Unknown Phase 2

• 1 other identifier: B2019-205R
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a prospective, single-arm study to evaluate the safety and feasibility of neoadjuvant therapy with anti-PD-L1 antibody (SHR-1316, Hengrui Medicine) in patients with resectable esophageal squamous cell carcinoma (ESCC).

Conditions

Oesophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response

  The primary endpoint is objective response (according to the Response Evaluation Criteria In Solid Tumors, version 1.1).

  Through the study completion, an average of 12 weeks

Secondary Outcomes (2)

• Adverse events and treatment-related adverse events

  Through the study completion, an average of 12 weeks

• Correlation between genetic profile and tumor response

  Through the study completion, an average of 12 weeks

Study Arms (1)

NeoAdjuvant Therapy With PD-L1 Antibody SHR-1316 group

EXPERIMENTAL

Patients will receive the neoadjuvant therapy with SHR-1316 followed by the operation.

Drug: PD-L1 Antibody SHR-1316

Interventions

PD-L1 Antibody SHR-1316 DRUG

Neoadjuvant therapy with immunoreagent (PD-L1 antibody SHR-1316) for resectable oesophageal squamous cell carcinoma

Also known as: PD-L1 antibody

NeoAdjuvant Therapy With PD-L1 Antibody SHR-1316 group

Eligibility Criteria

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

You may qualify if:

• The patients should be diagnosed with squamous cell cancer by gastroscopic biopsies and the tissue samples should be collected before the treatment.
• The primary tumor should be located in the thorax; the primary site is decided by the upper margin of the mass (upper thoracic esophagus: from the thoracic inlet to inferior margin of azygos arch, the endoscopic examination shows 20-25cm to the incisor; middle thoracic esophagus: from inferior margin of azygos arch to the inferior pulmonary vein level, the endoscopic examination shows 25-30cm to the incisor; lower thoracic esophagus: from the inferior pulmonary vein level to the stomach, the endoscopic examination shows 30-40cm to the incisor).
• The patients should be evaluated to be able to have surgical resection before the surgery according to the examinations (use enhanced thoracic and abdominal CT, cervical lymph node ultrasound to evaluate whether the tumor has obvious invasion, whether there are enlarged mediastinal lymph nodes; use examinations including positron emission computed tomography (PET-CT), endoscopic ultrasonography (EUS) to make further clinical staging if considering the primary tumor as T4b, multiple mediastinal lymph nodes metastasis or distant metastasis).
• The patients should be at the range of 18-75 years old, Eastern Cooperative Oncology Group (ECOG) 0-1, the estimated survival time should be over 12 months.
• The recipients should have no functional disorders in main organs. Blood routines, functions of lung, liver, kidney and heart should be basically normal, the label test index should accord with the demands as follows: Blood: white blood cell count (WBC)\>4.0\*10\^9/L, absolute neutrophil count (ANC)≥2.0\*10\^9/L, platelet count (PLT)\>100\*10\^9/L, hemoglobin (HBG)\>90g/L; Pulmonary function: Forced Expiratory Volume in the first second (FEV1)≥1.2 L, FEV1%≥50%, carbon monoxide diffusing capacity (DLCO)≥50%; Liver function: Serum bilirubin should be lower than 1.5 times of the maximum normal value; Alanine aminotransferase (ALT) and Aspartate transaminase (AST) should be lower than 1.5 times of the maximum normal value; Renal function: serum creatinine (SCr)≤120μmol/L creatinine clearance rate （CCr）≥60ml/min;
• The patients should be able to understand our research and sign the informed consent.

You may not qualify if:

• The stage of tumor is T4b (AJCC/International Union Against Cancer (UICC) 8th Edition) which can not be resected according to imaging examinations like thoracic and abdominal enhanced CT, cervical lymph nodes ultrasound, whole body PET-CT scan (optional) or endobronchial ultrasonography (EBUS) (optional); several enlarged lymph nodes existed (≥3 estimated lymph nodes metastasis); multiple station enlarged lymph nodes existed (≥2 estimated stations of lymph nodes metastasis); distant metastasis existed.
• The patients have accepted or are on the process of other chemotherapy, radiotherapy or targeted therapy.
• Endoscopic examination shows non-squamous carcinoma.
• The patients have history of other tumors (not include history of carcinoma in situ of the cervix, cured localized skin basal cell carcinoma).
• The patients have history of autoimmune diseases.
• The patients have recently taken steroids or immune immunosuppressive agents or are taking them.
• The patients have history of immunotherapy.
• The patients have history of severe hypersensitivity to antibody drugs.
• The patients have history of chronic or recurrent autoimmune diseases.
• The patients have interstitial lung disease, pulmonary fibrosis, diverticulitis or systematic ulcerative gastritis.
• The patients have proved history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control.
• The patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy.
• Female who is positive for serum pregnancy test or during lactation period, or people at child bearing stage who are reluctant to use contraception measures during the research.
• The patients have active infection of HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) or be HIV serum positive; or HBV, HCV RNA positive.
• The patients are allergic for any of the drugs in the research.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

180 Fenglin Road

Shanghai, 200032, China

RECRUITING

Related Publications (1)

• Yin J, Yuan J, Li Y, Fang Y, Wang R, Jiao H, Tang H, Zhang S, Lin S, Su F, Gu J, Jiang T, Lin D, Huang Z, Du C, Wu K, Tan L, Zhou Q. Neoadjuvant adebrelimab in locally advanced resectable esophageal squamous cell carcinoma: a phase 1b trial. Nat Med. 2023 Aug;29(8):2068-2078. doi: 10.1038/s41591-023-02469-3. Epub 2023 Jul 24.

  PMID: 37488287 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Lijie Tan, MD, PhD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lijie Tan, MD, PhD

CONTACT

8613681972151; tan.lijie@zs-hospital.sh.cn

Jun Yin, MD, PhD

CONTACT

8613917483128; yin.jun2@zs-hospital.sh.cn

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: December 27, 2019
• First Posted: January 2, 2020
• Study Start: February 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the study is completed.
• Access Criteria: IPD will be uploaded for access of other researchers.

Locations

CN (1)