A Real-world Study of Adebrelimab-based Combination Regimens in the Treatment of Advanced Solid Tumors

NCT07173244 | Not Yet Recruiting

• 1 other identifier: cancer-rws-001
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective, multicenter, non-interventional, observational, real-world study was designed to evaluate the safety and efficacy of an adebrelimab-based regimen in patients with advanced solid tumors.

Conditions

Non-Small Cell Lung Cancer; Small Cell Lung Cancer; Gastrointestinal Cancers

Outcome Measures

Primary Outcomes (1)

• The rate of treatment-related adverse reactions(TRAE)/immunotherapy-related adverse reactions/(irAE) and grade ≥ 3 TRAE/irAE

  The rate of treatment-related adverse reactions(TRAE)/immunotherapy-related adverse reactions/(irAE) and grade ≥ 3 TRAE/irAE, based on CTAE 5.0

  Through study completion, an average of 1 year

Secondary Outcomes (5)

• The rate of treatment Mode

  Through study completion, an average of 1 year

• The rate of treatment Mode

  Through study completion, an average of 1 year

• The rate of Treatment efficacy

  Through study completion, an average of 1 year

• The rate of Treatment efficacy

  Through study completion, an average of 1 year

• The rate of Treatment efficacy

  Through study completion, an average of 1 year

Study Arms (1)

Arm 1

adebrelimab-based regimen

Drug: Adebrelimab

Interventions

Adebrelimab DRUG

adebrelimab-based regimen

Arm 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced/recurrent or metastatic solid tumors were eligible for adebrelimab-based monotherapy or combination therapy at the investigator's discretion at the time of enrollment. Patients with central nervous system tumors, urinary system tumors, reproductive system tumors, bone tumors, soft tissue sarcomas, melanoma, and other skin tumors were excluded.

You may qualify if:

• Signed informed consent and voluntarily enrolled in this study;
• Histologically or cytologically confirmed extensive-stage small cell lung cancer;
• Patients with other types of advanced solid tumors confirmed by histology or cytology; patients who, based on currently available data, the investigator believes may benefit from adebrelimab treatment may also be considered for enrollment;
• Patients in Cohort 1 who experience disease progression and whose second-line treatment options, as assessed by the investigator, include adebrelimab in combination therapy may be enrolled in Cohort 2;
• Age 18-80 years;
• Patients deemed by the investigator to be eligible for adebrelimab monotherapy or combination therapy;
• Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the first dose of study drug (Cycle 1, Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Females and males of childbearing potential must agree to use appropriate contraceptive methods or undergo surgical sterilization during the trial and within 90 days after the last dose of the trial drug.
• Ability to comply with study and follow-up procedures.

You may not qualify if:

• Women who have been confirmed to be pregnant or breastfeeding;
• Patients with histologically or cytologically confirmed central nervous system tumors, urinary system tumors, reproductive system tumors, bone tumors, soft tissue sarcomas, melanomas and other skin tumors;
• Patients with a history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
• Patients with known allergies to adebrelimab or any of its drugs and excipients;
• Patients who are deemed by the investigator to be unsuitable for participation in this study in any other circumstances, including but not limited to the following: (1) Patients with autoimmune diseases (AIDs), especially neurological AIDs, or AIDs that are moderate to severe or in active stage and cannot be controlled by immunosuppressants or require high-dose immunosuppressants to control symptoms; (2) Patients with tuberculosis infection, active tuberculosis, and suspected active TB should be examined by chest X-ray, sputum, and clinical symptoms and signs to exclude; (3) The patient has previously received or is about to receive solid organ transplantation or hematopoietic stem cell transplantation; (4) The patient needs to use large doses of antibiotics, glucocorticoids, proton pump inhibitors and other drugs for a long time.

Sponsors & Collaborators

• Tianjin First Central Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Central Study Contacts

Wei Jiang Tianjin First Central Hospital, Professor

CONTACT

130 7220 1699; wangguohuipku@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 15, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share