Not Yet RecruitingNot Applicable

Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Patient Access Program

120 participantsStarted 2026-05

Plain-language summary

Envafolimab is a novel PD-L1 inhibitor administered via subcutaneous (SC) injection - notably the first such checkpoint inhibitor approved for use worldwide.\[1\] In November 2021, Envafolimab received its first approval in China for adults with advanced microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) solid tumors that have progressed after standard therapies. This SC route offers substantial practical advantages, significantly shortening treatment administration time and sparing patients from the adverse effects associated with intravenous infusions. Early clinical trials have demonstrated that Envafolimab can induce durable tumor responses, with objective response rates \~45% (including \~12% complete responses) observed in dMMR/MSI-H cancers. The therapy has also shown a favorable tolerability profile, with no infusion-related reactions and low rates of severe immune-mediated adverse events reported in initial studies.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adult patients (≥ 18 years) who received at least one dose of Envafolimab under the NPP between June, 2025 and Dec 31, 2026.
✓. 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).
✓. 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).
✓. 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).
✓. 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.
✓. 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

What they're measuring

Disease Control Rate (DCR)

Timeframe: From first dose through up to 6 months follow-up

Progression-Free Survival (PFS)

Timeframe: From first dose through up to 6 months follow-up

Overall Survival (OS)

Timeframe: From first dose through up to 6 months follow-up

Trial details

NCT IDNCT07562347

SponsorIR INNOVATE RESEARCH PRIVATE LIMITED

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-01

View on ClinicalTrials.gov More Advanced Solid Tumor trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adult patients (≥ 18 years) who received at least one dose of Envafolimab under the NPP between June, 2025 and Dec 31, 2026.
✓. 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).
✓. 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).
✓. 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).
✓. 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.
✓. 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).