Clinical trial · Interventional
Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.
Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer (IB3, IIA2) Patients
NCT06128460CI-TRIAL-00071854not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Locally advanced cervical cancer (stage IB3, IIA2) patients with postoperative risk factors need better treatment. We initiated a clinical study to explore the effectiveness of adjuvant chemoradiotherapy followed by Zimberelimab for these patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Platinum | Drug | Cisplatin | ALIAS |
| radiotherapy | Radiation | — | UNRESOLVED |
| Zimberelimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Concurrent themoradiotherapy Followed by Zimberelimab
- description
- 1. Radiotherapy: Intensity modulated conformal radiation therapy (IMRT) is used for external irradiation, and the pelvic target volume dose (PTV) is: 45-50 Gy/1.8Gy/25-28f; the stump margin is positive, and after the external irradiation is completed, Additional CT-guided three-dimensional conformal brachytherapy, HR-CTV: 24--30Gy/4-5f. 2. Concurrent chemotherapy: performed during external radiotherapy. Starting from the first week of radiochemotherapy, cisplatin 40 mg/m2 was given. Chemotherapy is given every 7 days, up to 5-6 times; 3. Zimberelimab injection: 240 mg/time, intravenous infusion, administered every 21 days, starting within four weeks after completing concurrent chemoradiotherapy, and maintained for 8 cycles
- interventionNames
- Drug: Zimberelimab
- Drug: Platinum
- Radiation: radiotherapy
Primary outcomes (1)
- measure
- changes in tumor-related biomarkers
- timeFrame
- 3 years
- description
- changes of tumor- related biomarkers (T cell receptor library profile and peripheral blood ctDNA content analysis)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adenosquamous carcinoma; * According to FIGO2018 staging, patients with locally advanced cervical cancer (IB3, IIA2) who require concurrent radiotherapy and chemotherapy; * Patients with radical surgery for cervical cancer; * Female patients: 18-70 years old; * ECOG physical condition score: 0\~1 point; * Subjects have not received previous immunotherapy; * Expected survival ≥6 months; * Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; * For adequate organ function as defined in the protocol, test samples must be collected within 7 days prior to initiation of the study therapy * Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up. Exclusion Criteria: * Subjects have histological subtypes other than those permitted by inclusion criteria; * Severe hypersensitivity to cepalizumab and/or any of its excipients (≥ grade 3); * Participate in or have participated in other clinical trials within 4 weeks before enrollment; * Have received or will receive inactivated vaccine within 30 days prior to the first study treatment; * Received a combination of systemic immune stimulants, colony-stimulating factors, interferon, interleukin, and vaccine within 6 weeks or 5 half-lives (if shorter) prior to initial administration; * Have been diagnosed with an immune deficiency or are receiving chronic systemic steroid therapy (doses greater than 10mg daily equivalent of prednisone) or any other form of immunosuppressive therapy within 7 days prior to the first dose; * Have an active autoimmune disease in the past 2 years that requires systemic treatment (such as the use of disease-modulating drugs, corticosteroids, or immunosuppressive drugs); * Have a history of (non-infectious) pneumonia requiring steroid treatment or have a current (non-infectious) pneumonia; * An active infection requiring systematic treatment; * Known history of HIV infection; * A known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as detection of HCV RNA\[qualitative\]) infection; * Known active tuberculosis (TB; Tuberculosis) medical history; * Has received allogeneic tissue/solid organ transplantation; * Suffering from central nervous system metastases such as brain metastases; * Patients with uncontrolled chest and abdominal fluid; * Patients with mobility disorders such as pathological fractures caused by tumor bone metastasis; * Insufficient hematopoietic function of bone marrow; * Abnormal liver; * Abnormal kidney; * Bleeding risk; * Cardiovascular and cerebrovascular abnormalities.
References
Publications (0)
Data not yet available
No reference posted for this study.