Prospective, Single-arm Phase II Exploratory Study of the Efficacy and Safety of IBI110 Combined With Sintilimab in Advanced or Metastatic Esophageal Squamous Cell Carcinoma That Has Failed First-line Anti-PD-1 Antibody Therapy

The First Affiliated Hospital of Zhengzhou University1 site in 1 country46 target enrollmentOctober 2023

ConditionsEsophageal Squamous Cell Carcinoma (ESCC)PD-1 Inhibitors

InterventionsIBI110+Sintilimab

DrugsIBI110+Sintilimab

Overview

Phase: Phase 2
Intervention: IBI110+Sintilimab
Conditions: Esophageal Squamous Cell Carcinoma (ESCC)
Sponsor: The First Affiliated Hospital of Zhengzhou University
Enrollment: 46
Locations: 1
Primary Endpoint: 1 year overall survival rate
Status: Not Yet Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-center, prospective, single-arm Phase II clinical study to evaluate the efficacy and safety of IBI110 in combination with Sintilimab in subjects with advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have failed first-line treatment with PD-1 inhibitors combined with chemotherapy.

Patients who meet the inclusion criteria will be treated with IBI110 combined with Sintilimab until disease progression, death, toxicity intolerance, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of therapy for other reasons specified in the protocol. RECIST v1.1 was used for clinical tumor imaging evaluation every 6 weeks during treatment.

Registry

clinicaltrials.gov

Start Date

October 2023

End Date

October 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The First Affiliated Hospital of Zhengzhou University

Responsible Party

Principal Investigator

Feng Wang

Doctor

The First Affiliated Hospital of Zhengzhou University

Eligibility Criteria

Inclusion Criteria

•Sign written informed consent prior to the implementation of any procedures related to the trial, and be able to comply with protocol visits and related procedures;
•Age ≥18 years old and ≤75 years old;
•Unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma confirmed by histopathological examination (excluding adenosquamous cell carcinoma mixed type and other pathological types);
•Disease progression must have previously received first-line anti-PD-1 antibody combined with chemotherapy, and disease progression must occur after at least 2 imaging evaluations after anti-PD-1 therapy (the second imaging evaluation is not less than 84 days after the first anti-PD-1 therapy); And the best efficacy evaluation of CR or PR population; It takes ≥6 months for the disease to stabilize in SD population.
•First-line chemotherapy includes fluorouracil combined with cisplatin or paclitaxel combined with cisplatin;
•Did not receive any systematic therapy, such as chemotherapy, targeted therapy, immunotherapy or other therapy, for 21 days before enrollment;
•Occurrence of immune-related adverse events during prior treatment with anti-PD-1 antibodies, except for the following: a.Grade 3 or higher immune-related adverse events (ir-AE) occurred, except for asymptomatic non-bullous or non-exfoliating rashes;b.did not recover from grade 2 immune-related adverse events (ir-AE);c.any adverse events leading to permanent discontinuation of PD-1;
•Note: Any level of toxicity that requires replacement therapy and is stable (such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is permissible.
•There was at least one radiographically measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST v1.1 edition).
•ECOG score 0-1;

Exclusion Criteria

•Esophageal squamous cell carcinoma known to be prone to complete obstruction under endoscopy requires interventional therapy to relieve the obstruction;
•After stent implantation in esophagus or trachea; Patients who are at high risk of bleeding or perforation due to significant tumor invasion of adjacent organs (aorta or trachea), or who have developed fistulas;
•Malignant diseases other than esophageal cancer diagnosed within 3 years prior to initial administration (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection);
•An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to initial administration. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy;
•Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
•Allergy to Sintilimab, IBI110 active ingredients or excipients of this study is known;
•Prior treatment with anti-LAG-3 antibodies;
•Has not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or hair loss);
•Received the following treatment:
•Received systemic anti-tumor therapy within 3 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal therapy with anti-tumor indications), etc.;