AzTrials
AzTrials

Cervical CancerNCT06062589

AK104 Combined With I-125 Brachytherapy for Recurrent or Metastatic Cervical Cancer

An observational study of Cervical Cancer, run by Peking University Third Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this study is to determine efficacy and safety of AK104 combined with I-125 brachytherapy for recurrent or metastatic cervical cancer. This is an open-label, single-center, observational study of AK104 with Iodine-125 brachytherapy in the treatment of recurrent or metastatic cervical cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Iodine-125 particle brachytherapy and AK104
Type of treatment
Surgery or procedure
How many people
18 participants
Where
No sites listed yet
Study dates
11 Oct 2023to 11 Oct 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with unresectable recurrent or metastatic cervical cancer who have undergone radical surgery and/or radical chemoradiotherapy and are suitable for local radiotherapy (non-central pelvic recurrence or oligometastasis in stage IVB).

Who may be able to join

  • Histologically or cytologically confirmed cervical cancer, with recurrence or metastasis after previous systemic surgery, postoperative chemoradiotherapy, or radical chemoradiotherapy, and suitable for local radiotherapy (non-central pelvic recurrence or oligometastasis in stage IVB).
  • Pathologically and radiologically confirmed tumor with maximum diameter not exceeding the maximum diameter for particle treatment (5-7cm).
  • Age ≥18 years and ≤70 years, female at the time of signing the informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1, able to tolerate puncture.
  • Measurable lesions according to RECIST 1.1, with target lesions unsuitable for surgical treatment.
  • Expected survival time of more than 3 months.
Show all 18Show fewer
  • Adequate organ function as per standard criteria for immunotherapy:
  • Absolute neutrophil count (ANC) ≥1.5×109/L
  • Platelets ≥75×109/L
  • Hemoglobin ≥90 g/L
  • Serum albumin ≥30 g/L
  • Total bilirubin (TBil) ≤1.5×ULN
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5×ULN; if there is liver metastasis, ALT and AST <5×ULN
  • Serum creatinine ≤1.5×ULN
  • Blood urea nitrogen (BUN) ≤2.5×ULN
  • Thyroid-stimulating hormone (TSH) ≤ upper limit of normal (ULN); if abnormal, investigate T3 and T4 levels, and if T3 and T4 levels are normal, the patient may be eligible.
  • Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days before starting study drug and agree to use a medically acceptable method of contraception during the study and for 3 months after the last dose of study drug.
  • Signed informed consent and the subject must understand the purpose of the study and the requirements for participation and voluntarily agree to participate.

Who cannot join

  • Potential subjects who meet any of the following criteria should be excluded from the study:
  • History of using anti-PD-1 antibodies, anti-CTLA-4 antibodies, TCR-T, CAR-T, or other immunotherapy within the past 4 weeks before the first dose, or participation in other anti-tumor drug clinical trials within the past 4 weeks before the first dose, or planned use of attenuated live vaccines during the study period.
  • Diagnosis of any other malignant tumor within the past 3 years.
  • Use the first dose, excluding intranasal and inhaled corticosteroids or physiologic doses of systemic corticosteroids (not exceeding 10 mg/day prednisolone or equivalent).
  • Patients with symptomatic, visceral metastasis, or short-term life-threatening complications risk, including uncontrollable large effusions (pleural, pericardial, or peritoneal), lymphangitis carcinomatosis, and 30% or more liver involvement.
  • Presence of any active autoimmune disease or history of autoimmune disease, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism. Patients with vitiligo or childhood asthma that has been completely resolved without any intervention during adulthood can be included. Patients with asthma requiring bronchodilators for medical intervention cannot be included.
Show all 16Show fewer
  • Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despite optimal medical management).
  • Grade II or higher myocardial ischemia or myocardial infarction, uncontrolled arrhythmia (including QTc interval ≥450 ms for males or ≥470 ms for females), NYHA class III-IV heart failure, left ventricular ejection fraction (LVEF) <50% as determined by echocardiography. Patients who experienced myocardial infarction, New York Heart Association class II or higher heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or acute ischemia or active conduction system abnormalities based on electrocardiogram within 6 months before enrollment.
  • Coagulation abnormalities (INR >1.5 or prothrombin time (PT) > upper limit of normal (ULN) + 4 seconds or APTT >1.5 ULN), bleeding tendency, or receiving thrombolysis or anticoagulation therapy.
  • Presence of obvious hemoptysis or expectoration of at least half a teaspoon (2.5 ml) of blood within 2 months before enrollment; or occurrence of significant clinically relevant bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline occult blood++ in stool, or vasculitis within 3 months before enrollment; or occurrence of arterial/venous thromboembolic events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, or cerebral infarction), deep vein thrombosis, or pulmonary embolism within 6 months before enrollment.
  • Severe infection within 4 weeks before the first dose (e.g., requiring intravenous administration of antibiotics, antifungals, or antiviral agents), or unexplained fever >38.5°C during screening or within 4 weeks before the first dose.
  • History of substance abuse, inability to discontinue substance abuse or presence of psychiatric disorders.
  • Major surgery within 4 weeks before the first dose or presence of open wounds or fractures.
  • Factors significantly affecting oral drug absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction; or occurrence of fistula or perforation of hollow organs within 6 months.
  • Urinalysis showing urine protein ≥++, or confirmed 24-hour urine protein ≥1.0 g.
  • Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥500 IU/ml), hepatitis C (positive HCV antibodies and HCV-RNA above the detection limit of the assay), or concurrent infection with both hepatitis B and hepatitis C.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ping Jiang contact

13439796018

drjiangping@qq.com

Xiuwen Deng contact

15811123680

justshowen@163.com

About this study

Official title: AK104 Combined With Iodine-125 Brachytherapy in the Treatment of Recurrent or Metastatic Cervical Cancer

The goal of this study is to determine efficacy and safety of AK104 combined with I-125 brachytherapy for recurrent or metastatic cervical cancer.

This is an open-label, single-center, observational study of AK104 with Iodine-125 brachytherapy in the treatment of recurrent or metastatic cervical cancer. 18 eligible patients will receive Iodine-125 brachytherapy (single implantation, half-life of 60 days, 99% of total dose given after 90 days), followed by AK104 treatment (6mg/kg Q2W) starting within 1 week of particle implantation, for a total of 6 cycles or until disease progression, intolerable toxicity, investigator decision, withdrawal of informed consent, death, or other reasons as specified in the protocol.

Read the detailed description

Study Title AK104 combined with Iodine-125 brachytherapy in the Treatment of Recurrent or Metastatic Cervical Cancer

Study Objectives Primary Objective To explore the effectiveness of AK104 in combination with Iodine-125 brachytherapy in the treatment of recurrent or metastatic cervical cancer.

Secondary Objective To explore the safety of AK104 in combination with Iodine-125 brachytherapy in the treatment of recurrent or metastatic cervical cancer.

Study Endpoints Primary Endpoint Objective response rate (ORR) based on RECIST 1.1 evaluation.

Secondary Endpoints Disease control rate (DCR), progression-free survival (PFS), and 3-year overall survival rate (OS) based on RECIST 1.1 evaluation.

Safety assessment: Incidence and severity of adverse events (AE), clinically significant abnormal laboratory test results.

Target Population Patients with unresectable recurrent or metastatic cervical cancer who have undergone radical surgery and/or radical chemoradiotherapy and are suitable for local radiotherapy (non-central pelvic recurrence or oligometastasis in stage IVB).

Study Drug and Administration AK104, 6mg/kg Q2W, administered via intravenous infusion over 60 minutes (±10 minutes). For subjects unable to tolerate a 60-minute infusion, the infusion time may be extended up to 120 minutes. Dose adjustments are not allowed during treatment with AK104, but treatment may be delayed for a maximum of 12 weeks from the previous dose. Treatment will be discontinued if AK104 has been withheld for more than 12 weeks due to treatment-related immune-related adverse events (irAE) requiring corticosteroid therapy, or for reasons unrelated or potentially unrelated to AK104, but the investigator determines that the patient would benefit from continued treatment after discussion with the medical monitor.

Conditions
Cervical Cancer
Being tested
Iodine-125 particle brachytherapy, AK104
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Iodine-125 particle brachytherapyRadiation

    All enrolled patients' relapsed or metastatic lesions underwent image-guided radiation I-125 particle implantation brachytherapy (single implantation, half-life of 60 days, 99% of total dose given after 90 days). The prescribed dose is above 130Gy. Technical process: positioning and preoperative planning design; Template reset and particle implantation under the guidance of image system; Rapid and real-time intraoperative optimization; Postoperative dose validation.

  • AK104Drug

    Also called Cadonilimab

    AK104 treatment (6mg/kg Q2W) starting within 1 week of particle implantation, for a total of 6 cycles or until disease progression, intolerable toxicity, investigator decision, withdrawal of informed consent, death, or other reasons as specified in the protocol.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    ORR was assessed by the site Investigator using RECIST 1.1 and was defined as the percentage of patients with a confirmed overall response of CR or PR

    Measured: From Baseline to 3 months

Secondary outcomes (4)

  1. Disease control rate (DCR)

    DCR was assessed by the site Investigator using RECIST 1.1 and was defined as the percentage of patients with a confirmed overall response of CR or PR or SD.

    Measured: From Baseline to 2 years]

  2. Progression-free survival (PFS)

    the time of all participants from the start of the treatment to tumor progression

    Measured: From Baseline to 2 years]

  3. Overall survival rate (OS)

    the time from the start of the treatment to the death of any cause.

    Measured: : From Baseline to 3 years]

  4. The adverse events

    The adverse events according to NCI-CTCAE v5.0

    Measured: From Baseline to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2023
  2. Study start11 Oct 2023 (estimated)
  3. Primary completion11 Jan 2025 (estimated)
  4. Study completion11 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06062589
Sponsor's protocol ID
M2023109
Status last verified
Jul 2023
First submitted
25 Sep 2023
Last updated
2 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Cancer, run by Peking University Third Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ping Jiang (13439796018, drjiangping@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: From Baseline to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06062589.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in