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New treatment option for Cervical Cancer
Official title Cadonilimab Plus Anlotinib for R/M/P Cervical Cancer
ClinicalTrials.gov ID: NCT05817214
What this study is testing
What is Cadonilimab?
Cadonilimab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for cervical cancer.
Also referred to as AK104.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to test a new treatment combination including cadonilimab, anlotinib and granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent, metastasis and persistent cervical cancer. The main questions it aims to answer are: The efficacy of this combination in R/M/P CC; The tolerance of this combination in R/M/P CC; Possible biomarker of treatment response for this combination.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Obtain informed consent signed by the patient or their legal representative;
- Female patients aged ≥18 and ≤75 years old;
- ECOG PS score of 0-1;
- Expected survival period ≥6 months;
- Pathological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma originating from the cervix;
You likely can't join if
- Translation:
- Any unstable systemic diseases, including but not limited to active infections within 4 weeks (defined as fever exceeding 38.5°C, evidence of...
- History of autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune liver diseases, systemic...
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis (hepatitis B, defined as HBV-DNA ≥...
- History of attenuated live vaccine administration within 28 days before the first dose of the study drug or expected attenuated live vaccine...
- Tumor invasion of major blood vessels on imaging or investigator judgment indicating a high risk of tumor invasion of important vessels causing fatal...
See the full eligibility criteria
Who can join
- Obtain informed consent signed by the patient or their legal representative;
- Female patients aged ≥18 and ≤75 years old;
- ECOG PS score of 0-1;
- Expected survival period ≥6 months;
- Pathological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma originating from the cervix;
- Can provide tumor tissue specimens archived within 2 years or willing to undergo tumor tissue biopsy to provide fresh specimens for further testing;
- At least one evaluable lesion meeting the criteria of RECIST 1.1;
- Have only received standard first-line systemic treatment in the past: (1) If first-line treatment does not include immunotherapy, failure of first-line treatment is sufficient (for patients who have previously achieved...
- Sitting blood pressure in a resting state is below the normal high value (\<140/90 mmHg), or 24-hour dynamic blood pressure monitoring average blood pressure is below the normal high value (\<140/90 mmHg), regardless of...
- Hematological indicators meet the following criteria (not transfused or administered hematopoietic growth factor drugs within the past 7 days): white blood cell count (WBC) ≥3.5×109/L, absolute neutrophil count (ANC)...
- Liver function indicators meet the following criteria: ALT and AST ≤2.5 times the upper limit of normal (ULN), bilirubin ≤1.5×ULN, albumin ≥35g/L;
- Coagulation function indicators meet the following criteria (not receiving anticoagulant or hemostatic drug therapy): PT and APTT ≤1.5×ULN, while INR ≤1.5 ULN;
- Renal function indicators meet the following criteria: blood urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN, urinary protein \<2+ or 24-hour urinary protein quantification \<1g;
- Women of childbearing age must undergo serum pregnancy testing within 7 days before initial medication, with negative results, and not be lactating. Female people of childbearing age must agree to use effective...
- Good compliance.
What rules you out
- Translation:
- Any unstable systemic diseases, including but not limited to active infections within 4 weeks (defined as fever exceeding 38.5°C, evidence of bacteremia, or evidence of infectious changes in the heart, brain, kidneys...
- History of autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune liver diseases, systemic vasculitis, scleroderma, dermatomyositis, autoimmune hemolytic anemia;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml; hepatitis C, defined as HCV-RNA higher than the detection...
- History of attenuated live vaccine administration within 28 days before the first dose of the study drug or expected attenuated live vaccine administration during the study period;
- Tumor invasion of major blood vessels on imaging or investigator judgment indicating a high risk of tumor invasion of important vessels causing fatal bleeding or other diseases with a high risk of severe bleeding;
- Previous treatment with anlotinib or cadonilimab;
- Evidence of active tuberculosis infection within the past year before screening;
- Diagnosis of any other malignant tumors, adequately treated basal cell carcinoma or squamous cell skin carcinoma, or cervical carcinoma in situ within 5 years before entering the study;
- Major surgery within 28 days before randomization (tissue biopsy for diagnostic purposes and insertion of a central venous catheter via percutaneous puncture are allowed);
- Active venous or arterial thromboembolic events within 6 months before randomization, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism;
- Previous or planned allogeneic bone marrow or solid organ transplantation;
- Clinically significant intestinal obstruction, occurrence of intestinal repair, intestinal anastomosis, intestinal diversion, or enterocutaneous fistula for any reason at any time;
- Participants who experienced symptoms of hemoptysis within 2 months before entering the study and had a maximum daily hemoptysis volume of approximately ≥2.5 mL. Participants who experienced significant bleeding...
- Visible hematuria or other evidence of active urinary system bleeding;
- Currently receiving thrombolysis or requiring long-term anticoagulant therapy with warfarin or heparin, or requiring long-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day);
- Known allergy to anlotinib, cadonilimab or any of their excipients;
- Participation in any other drug clinical studies within the previous 4 weeks before randomization or within 5 half-lives of the last study drug administration;
- History of substance abuse, alcoholism, or drug addiction;
- Coexisting severe cognitive impairment and inability to achieve stable mental status;
- As judged by the investigator, patients may have other factors that could lead to premature termination of the study, such as other serious illnesses or severe laboratory abnormalities, or factors affecting the safety...
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.