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OncoMatch/Clinical Trials/NCT07776821

An Exploratory Study on the Efficacy and Safety of Enlonstobart Combined With Concurrent Radiotherapy and Chemotherapy Following Induction Therapy With Enlonstobart Plus Chemotherapy in Patients With Locally Advanced Cervical Cancer.

Is NCT07776821 recruiting? Yes, currently enrolling (Sep 2026). This Phase 4 trial studies Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother for uterine cervical neoplasms.

Phase 4RecruitingTianjin Medical University Cancer Institute and HospitalNCT07776821Data as of Sep 2026Location: China

Treatment: Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiotherThe objective of this clinical trial is to investigate the efficacy and safety of Enlonstobart combined with concurrent chemoradiotherapy following induction chemotherapy for locally advanced cervical cancer. The primary questions it aims to address are: Can the Enlonstobart combination regimen improve the objective response rate and disease control rate in patients with locally advanced cervical cancer? What is the safety and tolerability profile of this combination regimen, and will any unexpected serious adverse events occur? Participants will: Receive induction therapy with Enlonstobart in combination with chemotherapy agents (e.g., paclitaxel plus platinum); Receive Enlonstobart in combination with concurrent chemoradiotherapy (external beam radiation therapy plus brachytherapy, with concurrent chemotherapy); Undergo regular tumor imaging evaluations (CT/MRI) and hematological safety assessments; Cooperate in completing efficacy assessments, adverse event documentation, and long-term follow-up.

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Extracted eligibility criteria

Treatments studied

Other

Enlonstobart combined with chemotherapy for induction therapy followed by concurrent radiother

Cancer type

Cervical Cancer

Disease stage

Required: Stage FIGO STAGE III, FIGO STAGE IV A (other)

locally advanced cervical cancer ... classified as FIGO stage III-IV A as of 2018

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75
Female only

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Lab requirements

Blood counts

ANC ≥ 1.5 × 10⁹/L, hemoglobin ≥ 90 g/dL, platelets ≥ 100 × 10⁹/L

Kidney function

Serum creatinine ≤ 1.5×ULN; if > 1.5×ULN, creatinine clearance ≥ 60 mL/min (Cockcroft-Gault)

Liver function

ALT, AST, ALP ≤ 2.5×ULN; if liver metastases present, ≤ 5×ULN; total bilirubin ≤ 1.5×ULN (≤ 3×ULN for Gilbert's syndrome)

Cardiac function

Left ventricular ejection fraction (LVEF) ≥ 50%

Bone marrow function: ANC ≥ 1.5 × 10⁹/L, hemoglobin ≥ 90 g/dL, platelets ≥ 100 × 10⁹/L; Liver function: ALT, AST, ALP ≤ 2.5×ULN; if liver metastases present, ≤ 5×ULN; total bilirubin ≤ 1.5×ULN (≤ 3×ULN for Gilbert's syndrome); Renal function: Serum creatinine ≤ 1.5×ULN; if > 1.5×ULN, creatinine clearance ≥ 60 mL/min (Cockcroft-Gault); Cardiac: LVEF ≥ 50%; Coagulation: PT, APTT, INR ≤ 1.5×ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07776821 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage FIGO STAGE III or FIGO STAGE IV A is required.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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