AzTrials
AzTrials

Locally Advanced Cervical CancerPhase 2NCT07450963

Cadonilimab Combined With RT in LACC Patients Ineligible for CCRT

A Phase 2 study testing Cadonilimab and RT in people with Locally Advanced Cervical Cancer, run by Ruijin Hospital.

Not yet recruiting

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

Official record
Search all trials

Trial summary

Concurrent chemoradiotherapy (CRT) is the standard of care for locally advanced cervical cancer (LACC). However, a substantial proportion of patients have contraindications to cisplatin based chemotherapy due to advanced age, renal impairment, cardiac dysfunction, or other comorbidities. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Locally Advanced Cervical Cancer
What is being tested?
Cadonilimab and RT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
No sites listed yet
Study dates
Mar 2026to Feb 2034
Phase
Phase 2
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female, age ≥18 years.
  • Histologically confirmed cervical squamous cell carcinoma or adenosquamous carcinoma.
  • FIGO 2018 stage IB3-IVA, or medically inoperable disease requiring definitive radiotherapy.
  • ECOG performance status 0-2, life expectancy ≥6 months.
  • Presence of at least one absolute or relative contraindication to concurrent cisplatin based chemotherapy, defined as:
  • Age ≥70 years; OR
Show all 14Show fewer
  • Renal impairment: serum creatinine >1.5 × upper limit of normal (ULN) or calculated creatinine clearance (CrCl) <50 mL/min (Cockcroft Gault); OR
  • Cardiac dysfunction: New York Heart Association class ≥II; OR
  • Prior allergic reaction to platinum agents; OR
  • Patient refusal of chemotherapy after thorough counselling.
  • Adequate organ function:
  • Total bilirubin ≤1.5 × ULN (≤3 × ULN for Gilbert's syndrome)
  • AST and ALT ≤2.5 × ULN
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Who cannot join

  • Prior or concurrent invasive malignancy unless disease free for ≥5 years (exceptions: non melanoma skin cancer, cured in situ carcinoma).
  • No histological confirmation of cervical cancer.
  • Prior exposure to anti PD 1/PD L1, anti CTLA 4, or other immune checkpoint inhibitors.
  • Congenital or acquired immunodeficiency (e.g., HIV infection).
  • Active hepatitis B (HBsAg positive with detectable HBV DNA) or hepatitis C (HCV RNA positive).
  • Pregnancy or lactation (negative serum/urine β hCG required for premenopausal women).
Show all 14Show fewer
  • Severe uncontrolled comorbidities precluding safe radiotherapy:
  • Unstable angina, myocardial infarction, or congestive heart failure requiring hospitalisation within 6 months
  • Acute bacterial or systemic fungal infection
  • Chronic obstructive pulmonary disease exacerbation requiring hospitalisation
  • Active connective tissue disease (e.g., systemic lupus erythematosus, scleroderma)
  • Psychiatric illness or social condition that would limit study compliance.
  • Inability to understand the study purpose or refusal to sign informed consent.
  • Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.

About this study

Official title: Cadonilimab Combined With Radical Radiotherapy in Locally Advanced Cervical Cancer Patients Ineligible for Concurrent Chemotherapy - A Prospective, Single Arm, Phase II Trial

Concurrent chemoradiotherapy (CRT) is the standard of care for locally advanced cervical cancer (LACC). However, a substantial proportion of patients have contraindications to cisplatin based chemotherapy due to advanced age, renal impairment, cardiac dysfunction, or other comorbidities. For these patients, no evidence based standardised treatment exists. Immunotherapy combined with radiotherapy may offer a chemotherapy sparing alternative. Cadonilimab, a PD 1/CTLA 4 bispecific antibody, has demonstrated significant efficacy in advanced cervical cancer. This study aims to evaluate the efficacy and safety of cadonilimab combined with radical radiotherapy in LACC patients ineligible for concurrent chemotherapy.

This is an investigator initiated, prospective, single centre, single arm, open label, Simon's two stage phase II trial. A total of 45 patients will be enrolled. Eligible participants are women aged >18 years with histologically confirmed cervical squamous cell carcinoma or adenosquamous carcinoma, FIGO 2018 stage IB3-IVA, and absolute or relative contraindications to cisplatin based chemotherapy. All patients will receive radical radiotherapy (external beam radiotherapy 45-50.4 Gy/25-28 fractions plus high dose rate brachytherapy 6-8 Gy × 3-5 fractions) concurrently with three cycles of cadonilimab 10 mg/kg intravenously every 3 weeks. The primary endpoint is complete response (CR) rate assessed at 4 weeks post radiotherapy. Secondary endpoints include 2 year progression free survival, 2 year local control, 2 year locoregional control, 5 year overall survival, safety (CTCAE v5.0 and RTOG late toxicity), and quality of life (EORTC QLQ C30 and QLQ BR23). Assuming a historical CR rate of 69% with radiotherapy alone, we hypothesise that the combination will increase CR to 85%. With α=0.05 (two sided) and 80% power, Simon's optimal two stage design requires 43 evaluable patients; after accounting for 5% dropout, 45 patients will be recruited.

Being tested
Cadonilimab, RT

What participants receive

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

  • CadonilimabDrug

    Cadonilimab will be administered as a 30-60 minute intravenous infusion at a dose of 10 mg/kg every 3 weeks for a total of 3 cycles. The first dose is scheduled within 3 days before or after the start of EBRT.

  • RTRadiation

    External beam radiotherapy (EBRT): Intensity modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT) with daily image guidance. Total dose: 45-50.4 Gy in 25-28 fractions (1.8-2.0 Gy per fraction), 5 fractions per week. Target volumes include the gross tumour volume (cervix), entire uterus, parametria, and pelvic lymph node regions (including common iliac, presacral, and obturator nodes). Paraaortic lymph node regions are included if involved.

    Brachytherapy (BT): High dose rate (HDR) intracavitary/interstitial brachytherapy starting in the final week(s) of EBRT or immediately after. Dose: 6-8 Gy per fraction, 3-5 fractions, prescribed to the high risk clinical target volume (HR CTV). Total EQD2 (α/β=10) to point A and HR CTV D90 should exceed 80 Gy.

Study groups in NCT07450963
Study groupRoleWhat they receive
Combined TreatmentExperimentalCadonilimab combined with Radical Radiotherapy
Receives: Drug: Cadonilimab; Radiation: RT

What is being measured

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

  1. Complete response (CR) rate

    The proportion of patients with disappearance of all target lesions (cervix and lymph nodes), no new lesions, and normalisation of tumour markers (e.g., SCC Ag), confirmed by pelvic MRI and/or PET CT and maintained for at least 4 weeks according to RECIST v1.1

    Measured: 5 year

Secondary outcomes (7)

  1. 2 year progression free survival

    Measured: 2 year

  2. 2 year local control rate

    Measured: 2 year

  3. 2 year locoregional control rate

    Measured: 2 year

  4. 5 year overall survival

    Measured: 5 year

  5. Acute adverse events (AEs)

    adverse events (AEs) according to CTCAE v5.0

    Measured: up to 3 months

  6. Late AE

    RTOG/EORTC

    Measured: up to 5 years

  7. Quality of life assessed by EORTC QLQ C30 score

    change from baseline in EORTC QLQ C30 score (0-100), higher scores mean a better outcome.

    Measured: up to 5 years

Timeline

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

  1. First posted5 Mar 2026
  2. Study startMar 2026 (estimated)
  3. Primary completionFeb 2029 (estimated)
  4. Study completionFeb 2034 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07450963
Sponsor's protocol ID
2026（56）
Status last verified
Mar 2026
First submitted
24 Feb 2026
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab and RT in people with Locally Advanced Cervical Cancer, run by Ruijin 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 14 inclusion and 14 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 5 Mar 2026. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response (CR) rate (time frame: 5 year). 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 NCT07450963.

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 5 Mar 2026.

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