IBI110 Combined With Sintilimab in Second-line Advanced or Metastatic Esophageal Squamous Cell Carcinoma(ESCC)

NCT06078657 | Unknown Phase 2

• 1 other identifier: CIBI110Y006
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma (ESCC); PD-1 Inhibitors

Outcome Measures

Primary Outcomes (1)

• 1 year overall survival rate

  The proportion of participants who were alive in the study from treatment to 1 year

  1 year

Secondary Outcomes (5)

• overall survival and progression free survival

  about 2 years

• objective remission rate

  about 2 years

• Disease control rate

  about 2 years

• Duration of remission

  about 2 years

• adverse events

  about 2 years

Other Outcomes (1)

• biomarker

  about 2 years

Study Arms (1)

IBI110 combined with Sintilimab

EXPERIMENTAL

Drug: IBI110+Sintilimab

Interventions

IBI110+Sintilimab DRUG

IBI110, 200mg, intravenously on the first day of each cycle, every 3 weeks for 1 cycle (Q3W), and the maximum use time was 2 years. Sintilimab, 200mg, intravenously on the first day of each cycle, every 3 weeks as a cycle (Q3W), and the maximum use time was 2 years.

IBI110 combined with Sintilimab

Eligibility Criteria

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

You may qualify if:

• 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;
• Expected survival time \>3 months;
• For adequate organ function, the subject must meet the following laboratory criteria:
• The absolute value of neutrophil (ANC) ≥1.5x109/L in the past 14 days without the use of granulocyte colony-stimulating factor;
• Platelets ≥100×109/L without blood transfusion in the past 14 days;
• Hemoglobin \>9g/dL in the last 14 days without blood transfusion or use of erythropoietin;

You may not qualify if:

• 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.;
• Received any investigational drug therapy within 4 weeks prior to treatment;
• Receiving excessive doses of immunosuppressive drugs (systemic corticosteroids exceeding 10mg/ day of prednisone or its equivalent) within 4 weeks prior to treatment;
• Received live attenuated vaccine within 4 weeks prior to treatment (or plan to receive live attenuated vaccine during the study period);
• Major surgery, or unhealed surgical wounds, ulcers, or fractures within 4 weeks prior to treatment.
• An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first administration. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy;

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

Feng Wang

Zhengzhou, Henan, 450052, China

Location

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 12, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

CN (1)