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Cervical CancerPhase 2CATPCC-01NCT06511726

Induction Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer

A Phase 2 study testing Cadonilimab, Cisplatin and Albumin-Bound Paclitaxel /nab-Paclitaxel in people with Cervical Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an investigator-initiated, single-arm, phase II clinical study evaluating the efficacy and safety of cadonilimab combined with induction chemotherapy followed by concurrent chemoradiotherapy (CCRT) in patients with locally advanced cervical cancer (LACC). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Cadonilimab, Cisplatin and Albumin-Bound Paclitaxel /nab-Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteChina
Study dates
23 Jan 2024to 30 Apr 2029
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

  • Patients with good compliance.
  • Age ≥ 18 years (calculated on the day of signing the informed consent).
  • Histologically or pathologically diagnosed with cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) and measurable lesions.
  • Initial diagnosis of stage IB3-IVA (according to FIGO 2018 staging).
  • ECOG performance score of 0-2.
  • Main organ functions meet the protocol criteria within 7 days before treatment.

Who cannot join

  • Patients with other histological types of cervical cancer, such as neuroendocrine carcinoma or sarcoma.
  • Evidence of distant metastasis, including groin lymph node metastasis and lymph node metastasis above the L1 level.
  • Previously underwent total hysterectomy (removal of the uterus body + cervix). History of subtotal hysterectomy or cervical wedge resection that preserves the cervix is allowed.
  • With anatomical abnormalities or tumor geometry-related contraindications that prevent the use of brachytherapy.
  • Within 2 years, had other active malignant tumors, except for locally curable tumors that have been cured, such as squamous cell carcinoma of the skin, basal cell carcinoma of the skin, superficial bladder cancer, and ductal carcinoma in situ of the breast.
  • With clinically significant bilateral hydronephrosis that, in the investigator's judgment, cannot be relieved by nephrostomy or ureteral stent placement.
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  • Previously received immune checkpoint inhibitors (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies) or any treatment targeting tumor immune mechanisms involving immune co-stimulatory factors (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40).
  • Within 2 weeks, requires the use of glucocorticoids (> 10 mg/day prednisone or equivalent dose of glucocorticoids) or other immunosuppressive drugs for systemic treatment exceptions include: a) Allowed treatment with inhaled, ophthalmic, or local doses ≤ 10 mg/day prednisone or equivalent dose of glucocorticoids. b) Physiological glucocorticoid replacement therapy at a dose ≤ 10 mg/day prednisone or equivalent dose of glucocorticoids. c) Glucocorticoids used for prophylaxis against hypersensitivity reactions (e.g., premedication for CT scans).
  • Within 2 weeks, received drugs with immunomodulatory effects (e.g., thymosin, interferon, interleukin-2).
  • Presence of active systemic infections requiring systemic treatment (including active pulmonary tuberculosis, active syphilis caused by Treponema pallidum, and fungal infections requiring systemic treatment) note: exclusion does not apply to antiviral drugs used for hepatitis B virus infection.
  • Within 4 weeks, experienced severe infections, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia.
  • Within 4 weeks, underwent major surgical treatment (as determined by the investigator), open biopsy, or significant trauma or requires scheduled major surgical treatment during the study. Diagnostic systematic pelvic/aortic lymphadenectomy is allowed.
  • Received live vaccines within 4 weeks .
  • With active or history of documented autoimmune diseases exceptions include: vitiligo, alopecia, psoriasis, or eczema that do not require systemic treatment hypothyroidism caused by autoimmune thyroiditis requiring stable dose of hormone replacement therapy type 1 diabetes requiring stable dose of insulin replacement therapy.
  • Any of the following cardiovascular diseases: a) New York Heart Association (NYHA) functional classification ≥ II for heart failure. b) Presence of severe arrhythmias requiring long-term drug intervention asymptomatic patients with stable ventricular rate in atrial fibrillation are allowed to enroll. c) Occurrence of cerebrovascular events (CVA) within 6 months . d) Left ventricular ejection fraction (LVEF) < 50%.
  • Known primary or secondary immunodeficiency, including positive human immunodeficiency virus (HIV) antibody test.
  • Subjects with active hepatitis B virus (HBV) infection, non-active or asymptomatic carriers of hepatitis B surface antigen (HBsAg) with HBV DNA > 1000 IU/mL, and subjects with active hepatitis C virus (HCV) infection. Note: Non-active or asymptomatic carriers with treated and stable hepatitis B infection with HBV DNA ≤ 1000 IU/mL are allowed to enroll. Subjects with cured hepatitis C infection, positive HCV antibody (HCVAb), and negative HCV RNA are allowed to enroll.
  • With active or documented history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis) or active diverticulitis.
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Known history of severe hypersensitivity reactions to other monoclonal antibodies.
  • Pregnant or breastfeeding women.
  • The investigator believes that there may be risks associated With receiving the investigational drug or any condition that may interfere With the evaluation of the investigational drug, subject safety, or interpretation of study results (such as having other severe diseases or mental disorders).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen Memorial hosipital

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: Induction Chemotherapy Plus Cadonilimab Followed by Chemoradiotherapy for Locally Advanced Cervical Cancer: A Multicenter, Open-label, Single-arm, Phase II Trial

This is an investigator-initiated, single-arm, phase II clinical study evaluating the efficacy and safety of cadonilimab combined with induction chemotherapy followed by concurrent chemoradiotherapy (CCRT) in patients with locally advanced cervical cancer (LACC). Despite standard concurrent chemoradiotherapy, patients with LACC remain at high risk of recurrence and distant metastasis. Cadonilimab, a PD-1/CTLA-4 bispecific antibody, has demonstrated promising antitumor activity in cervical cancer. This study aims to investigate whether induction immunochemotherapy with cadonilimab combined with cisplatin and albumin-bound paclitaxel can improve tumor response before definitive radiotherapy. In addition, the study will explore the association between treatment efficacy and dynamic changes in PD-L1 expression, peripheral blood immune-related biomarkers, and tumor microenvironment immune cell populations during treatment. The primary endpoint is objective response rate (ORR) assessed according to RECIST version 1.1, while secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.

Read the detailed description

This is an investigator-initiated, single-arm, phase II clinical study designed to evaluate the efficacy, safety, and tolerability of cadonilimab combined with induction chemotherapy in patients with locally advanced cervical cancer (LACC). The study also aims to explore the association between treatment efficacy and dynamic changes in PD-L1 expression, peripheral blood immune-related biomarkers, and tumor microenvironmental immune cell populations during treatment. A Simon two-stage design is adopted in this study. In the first stage, 9 patients will be enrolled. If 7 or fewer patients achieve an objective response, the study will be terminated for futility. Otherwise, the study will proceed to the second stage, with continued enrollment up to a total sample size of 29 patients. Patients will receive induction immunochemotherapy consisting of cadonilimab combined with cisplatin and albumin-bound paclitaxel for 2 cycles, followed by concurrent chemoradiotherapy (CCRT). During CCRT, cisplatin will be administered weekly at a dose of 30-40 mg/m² for 5 cycles. External beam radiotherapy (EBRT) will be delivered using 6-MV X-rays at a total dose of 45-60 Gy in 25 fractions, followed by brachytherapy with a prescribed dose of 30 Gy in 5 fractions. The primary endpoint is objective response rate (ORR) assessed according to RECIST version 1.1. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety, and treatment tolerability.

Conditions
Cervical Cancer
Being tested
Cadonilimab, Cisplatin, Albumin-Bound Paclitaxel /nab-Paclitaxel, Concurrent chemoradiotherapy
Keywords
cervical cancer, immunotherapy, Induction chemotherapy, Cadonilimab
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.

  • CadonilimabDrug

    Cadonilimab will be administered intravenously in combination with cisplatin and albumin-bound paclitaxel as induction immunochemotherapy for 2 cycles.

  • CisplatinDrug

    Cisplatin will be administered during induction chemotherapy and weekly during concurrent chemoradiotherapy.

  • Albumin-Bound Paclitaxel /nab-PaclitaxelDrug

    Albumin-bound paclitaxel will be administered intravenously in combination with cadonilimab and cisplatin during induction therapy.

  • Concurrent chemoradiotherapyRadiation

    External beam radiotherapy will be delivered using 6-MV X-rays at a total dose of 45-60 Gy in 25 fractions, followed by brachytherapy at a dose of 30 Gy in 5 fractions. Weekly cisplatin (30-40 mg/m²) will be administered concurrently during radiotherapy.

Study groups in NCT06511726
Study groupRoleWhat they receive
Cadonilimab plus induction chemotherapy followed by CCRTExperimentalPatients will receive induction immunochemotherapy consisting of cadonilimab combined with cisplatin and albumin-bound paclitaxel for 2 cycles, followed by concurrent chemoradiotherapy (CCRT). During CCRT, cisplatin will be administered weekly concurrently with external beam radiotherapy and brachytherapy.
Receives: Drug: Cadonilimab; Drug: Cisplatin; Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel; Radiation: Concurrent chemoradiotherapy

What is being measured

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

  1. ORR

    At 2 weeks post-induction therapy, objective response rate represents the proportion of patients showing a predefined level of tumor shrinkage or disappearance in response to treatment.

    Measured: up to18 months

Secondary outcomes (4)

  1. OS

    Overall survival measures the length of time from the start of treatment until death from any cause, indicating the effectiveness of the treatment in prolonging patients' lives.

    Measured: up to approximately 46 months

  2. PFS

    Progression-free survival measures the length of time during and after treatment that a patient lives with the disease without it progressing.

    Measured: up to approximately 46 months

  3. DCR

    DCR is the proportion of patients who have achieved complete response, partial response, or stable disease

    Measured: up to approximately 46 months

  4. Incidence of treatment-related adverse events (TRAEs)

    The proportion of patients experiencing treatment-related adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: From initiation of induction therapy to 90 days after completion of radiotherapy

Timeline

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

  1. First posted22 Jul 2024
  2. Study start23 Jan 2024
  3. Primary completion20 Nov 2024
  4. Study completion30 Apr 2029 (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
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06511726
Sponsor's protocol ID
SYSKY-2023-1101-04
Acronym
CATPCC-01
Status last verified
Apr 2026
First submitted
11 Jul 2024
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab, Cisplatin and Albumin-Bound Paclitaxel /nab-Paclitaxel in people with Cervical Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

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 6 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

ORR (time frame: up to18 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 NCT06511726.

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 4 Jun 2026.

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