Clinical trial NCT05437692: Zimberelimab Combined With Concurrent Radiotherapy and Chemotherapy for Locally Advanced Cervical Cancer
Official title: A Prospective, Single Arm, Phase II Clinical Study on the Treatment of Locally Advanced Cervical Cancer (Ⅱ B to Ⅳ a) With Zimberelimab Combined With Concurrent Radiotherapy and Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Locally Advanced Cervical Cancer
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single arm, phase II clinical study on the treatment of locally advanced cervical cancer (Ⅱ B to Ⅳ a) with Zimberelimab combined with concurrent radiotherapy and chemotherapy.

Detailed description: This study will include 19 patients with locally advanced cervical cancer to explore the efficacy and safety of Zimberelimab in combination with concurrent radiotherapy for them.

Eligibility criteria: Inclusion Criteria:

* FIGO 2018 stage IIB to IVA cervical cancer;
* Cervical squamous cell carcinoma, cervical adenocarcinoma or cervical adenosquamous carcinoma confirmed by histology;
* Have not received any radiotherapy for cervical cancer in the past, and have not received immunotherapy;
* Have measurable lesions (according to RECIST v1.1 standard);
* ECOG score: 0 \~ 1;
* 18\~75 years old (calculated on the day of signing the informed consent);
* The estimated survival period exceeds 6 months;
* Before enrollment, try to provide enough tumor tissue samples (archived or fresh biopsy samples) to evaluate and confirm the expression of PD-L1 and to detect other biomarkers; Considering the accessibility of clinical specimens, there is no mandatory requirement for specimens;
* Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within ● months after the end of the study; Within 7 days before the study was enrolled, the serum or urine pregnancy test was negative, and must be non lactating patients;
* For the full organ function defined in the protocol, the test samples must be collected within 7 days before the start of the study treatment;
* The patients volunteered to join the study and signed the informed consent form.

Exclusion Criteria:

* The subjects have other histological subtypes except those permitted by inclusion criteria 2;
* Bilateral hydronephrosis, unless at least one side has been implanted with a stent or solved by a positioned nephrostomy;
* Those who are allergic to gadolinium, a common non-ionic CT contrast agent and a magnetic resonance contrast agent
* Have anatomical structure or tumor geometry or any other reasons or contraindications that cannot be treated with intracavitary brachytherapy or intracavitary and implantable brachytherapy;
* Severe hypersensitivity (≥ grade 3) to cepalimumab and / or any of its excipients;
* Participated in or had participated in clinical trials within 4 weeks before randomization;
* Have been vaccinated or will be vaccinated with live vaccine within 30 days before the first study treatment;
* Have received systemic immune stimulant, colony stimulating factor, interferon, interleukin and vaccine combination treatment within 6 weeks or 5 half lives (whichever is shorter) before the first administration;
* Within 7 days before the first administration, the patient has been diagnosed with immune deficiency or is receiving chronic systemic steroid therapy (the dose exceeds 10mg prednisone equivalent per day) or any other form of immunosuppressive therapy;
* Active autoimmune diseases requiring systemic treatment during the past two years (such as the use of disease regulating drugs, corticosteroids or immunosuppressive drugs);
* Have a history of (non infectious) pneumonia requiring steroid treatment or currently have (non infectious) pneumonia;
* Active infection requiring systematic treatment;
* Known HIV infection history;
* Known hepatitis B (defined as HBsAg reactivity) or known active hepatitis C virus (defined as detection of HCV RNA \[qualitative\]) infection history;
* Known history of active tuberculosis (TB; Mycobacterium tuberculosis);
* Received allogeneic tissue / solid organ transplantation;
* Central nervous system metastasis such as tumor brain metastasis;
* Patients with uncontrolled hydrothorax and ascites;
* Patients with movement disorders such as pathological fractures caused by tumor bone metastasis;
* Insufficient hematopoietic function of bone marrow (without blood transfusion within 14 days):
* Abnormal liver:
* Abnormal kidney:
* Risk of bleeding:
* Cardiovascular and cerebrovascular abnormalities:

Primary outcomes:
measure: ORR
timeFrame: one year
Secondary outcomes:
measure: adverse events
timeFrame: two years
measure: DCR
timeFrame: one year
measure: OS
timeFrame: three years
measure: PFS
timeFrame: two years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Lin Genlai, MD
role: PRINCIPAL_INVESTIGATOR
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