Envafolimab in real-world use for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects retrospective data from multiple centers in five countries to describe how Envafolimab performs outside of controlled trials. It focuses on adults who received at least one dose under the Named Patient Program between June 2025 and December 2026. Primary endpoints include objective response rate, disease control rate, progression-free survival, and overall survival, while safety outcomes cover adverse events and immune-related toxicities. Data are sourced from anonymized medical records with descriptive statistics and Kaplan-Meier analyses for survival. The aim is to expand understanding of Envafolimab use in non-Chinese populations with limited prior data, while ensuring ethical and regulatory compliance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult patients (≥ 18 years) who received at least one dose of Envafolimab under the NPP between June, 2025 and Dec 31, 2026.
2. Histologically or cytologically confirmed diagnosis of a malignancy for which Envafolimab was prescribed under the NPP (e.g., an advanced solid tumor with MSI-H/dMMR or other approved/compassionate indications).
3. Measurable or evaluable disease at baseline, with at least one disease assessment (e.g. imaging or clinical evaluation) performed within 8 weeks before the first Envafolimab dose (to establish baseline tumor status).
4. At least one post-baseline disease assessment after starting Envafolimab, and a minimum follow-up duration of 6 months from the first dose (unless the patient has documented disease progression or died within 6 months).
5. Availability of sufficient clinical data in the medical records to evaluate baseline characteristics, treatment administration, tumor response, and safety outcomes. This includes baseline demographics, disease status, treatment dates, and follow-up assessments as required by the CRF.
6. Permission/approval for data use: Patient data can be utilized for research as per local ethical and regulatory requirements (e.g., institutional review board approval or waiver of consent for retrospective data collection, and compliance with data privacy laws).

Exclusion Criteria:

1. No evidence of Envafolimab administration: Patients for whom Envafolimab was requested or planned under NPP but never actually received a dose.
2. Insufficient follow-up: Patients with no post-baseline tumor assessment and less than 6 months of follow-up without documented disease progression or death. (Such patients would not contribute evaluable data for effectiveness.)
3. Missing critical baseline information in records, such as unknown index (start) date of Envafolimab therapy or lack of documented cancer diagnosis, precluding assessment of outcomes.
4. Prior Envafolimab exposure outside the NPP (e.g., via a clinical trial or other program) before the index date, unless specifically allowed (pre-specified exceptions, if any, will be outlined for instance, patients who switched from a clinical trial to NPP might be handled on a case by case basis).
5. Concurrent participation in any other interventional clinical trial at the time of starting Envafolimab (index date), to avoid confounding effects of other investigational treatments on outcomes.
6. Legal or ethical prohibitions on using the patient's data for research. For example, if local regulations or the patient's prior consent status prevent inclusion of their de-identified data in this study, they will not be enrolled.

Where it's running

• Nairobi South Hospital
  Nairobi, Kenya Recruiting
• C-Care Darny
  Floréal, Mauritius Not yet recruiting
• The Medical City South Luzon and Calamba Medical Center
  Laguna, Philippines Not yet recruiting
• St. Luke's Quezon City and National Kidney Transplant Institute
  Quezon City, Philippines Not yet recruiting

Study contacts

• Study coordinator: Dr.Devesh Kumar, Doctor
• Email: devesh.kumar@innovate-research.com
• Phone: +91-9971169602

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.