Actively Recruiting
Efficacy and Safety of AK104 Combined With Chemotherapy and Recombinant Human Adenovirus 5 Injection in Cervical Cancer
Led by Fujian Cancer Hospital · Updated on 2024-06-12
37
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
F
Fujian Cancer Hospital
Lead Sponsor
Z
Zhangzhou Municipal Hospital of Fujian Province
Collaborating Sponsor
AI-Summary
What this Trial Is About
In order to improve the clinical effect and find a new safe and effective treatment model for advanced recurrent cervical cancer, this study explored the efficacy level safety of pemetrexed, carboplatin, recombinant human adenovirus type 5, and AK104 regimen in recurrent and refractory advanced cervical cancer. For some patients with immune-resistant cervical cancer, combination chemotherapy and oncolytic virus therapy can promote the transformation of cold tumors into hot tumors, eliminate and then reverse the suppressor factors of immune resistance, and break the dilemma of immunotherapy drug resistance, which is a new method and strategy under immunotherapy drug resistance.
CONDITIONS
Official Title
Efficacy and Safety of AK104 Combined With Chemotherapy and Recombinant Human Adenovirus 5 Injection in Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary female participants aged 18 to 75 who sign informed consent and can follow study visits and procedures
- Confirmed persistent, recurrent, or metastatic cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- Failure of at least one standard systemic treatment with documented disease progression
- Not suitable for local treatments like surgery or concurrent radiotherapy and chemotherapy
- At least two weeks since last systemic treatment and recovery from treatment-related side effects to mild or less
- Presence of at least one measurable tumor lesion and one lesion eligible for adenovirus local injection per RECIST criteria
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Use of effective contraception during treatment and for five months after final dose if of reproductive age
- Consent to provide tumor tissue samples for PD-L1 testing
- Adequate organ and blood function
You will not qualify if you...
- Other cancers diagnosed in past 5 years except certain skin and thyroid cancers or specific cervical cancer types
- Infection at the injection site
- Symptomatic or draining ascites, pleural or pericardial effusion
- History of organ or bone marrow transplant
- Active hepatitis B or C infection above defined viral load
- Symptomatic or untreated brain metastases
- Recent life-threatening bleeding events
- Recent arterial thrombosis or embolism, uncontrolled hypertension, or serious heart conditions
- Severe bleeding disorders or current thrombolytic therapy
- Recent gastrointestinal perforation, fistula, or severe bowel disease
- Active or recent pneumonitis or tuberculosis
- Positive HIV or active syphilis infection
- Severe uncontrolled infections or recent antibiotic therapy
- Systemic autoimmune diseases requiring treatment or immunosuppressive drug use within four weeks
- Recent live attenuated vaccine or immune stimulant use
- Major surgery or unhealed wounds within four weeks
- Uncontrolled metabolic or systemic diseases
- Allergies to study drugs
- Recent investigational drug use or anticancer therapies within defined washout periods
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350011
Actively Recruiting
Research Team
Q
Qin Xu
CONTACT
L
Li Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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