Recurrent Cervical CarcinomaPhase 2NCT05310383
Tislelizumab and Radiotherapy for Recurrent Cervical Cancer
A Phase 2 study testing Tislelizumab plus radiotherapy in people with Recurrent Cervical Carcinoma and Metastatic Cervical Carcinoma, run by Lei Li at 1 site in China.
Trial summary
This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel plus bevacizumab for platinum-resistant recurrent epithelial ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Cervical Carcinoma, Metastatic Cervical Carcinoma, Persistent Cervical Carcinoma
- What is being tested?
- Tislelizumab plus radiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2022to 27 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- The patient voluntarily participates and signs informed consent
- Aged 18 years of age or older
- Has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 within 7 days prior to the first dose of study treatment
- Has recurrent cervical cancer and controllable local treatment, indicating an indication for radiation therapy
- Willing to accept concurrent radiotherapy combined with Tislelizumab
- Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the local investigator
- Has adequate organ function
- Has expected survival time ≥3 months
Who cannot join
- Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- Has a known history of Human Immunodeficiency Virus (HIV) infection，active Hepatitis virus infection and active tuberculosis (TB; Bacillus tuberculosis)
- Has known active central nervous system (CNS) metastases and/or uncontrolled, untreated carcinomatous meningitis with elevated intracranial pressure
- Has received a major surgery within 4 weeks prior to signing informed consent
- Not suitable for radiotherapy
- Reassessment of liver and kidney function and blood routine indexes after radiotherapy did not meet the above criteria
- Did not meet the other requirements for inclusion by the investigator
- Judged unqualified of the enrollment requirements by the researcher according to other conditions
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, M.D., 8613911988831, lileigh@163.com
About this study
Official title: Combination of Immune Checkpoint Inhibitors Tislelizumab and Radiotherapy for Recurrent, Metastatic and Persistent Advanced Cervical Cancer: A Single-arm, Single-center, Phase 2 Clinical Study
This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel plus bevacizumab for platinum-resistant recurrent epithelial ovarian cancer. Patients with platinum-resistant recurrent ovarian cancer who meet the inclusion criteria, and don't meet any of the exclusion criteria, are enrolled in the study. They will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. The total treatment periods are no more than 6 cycles. Treatment continue until disease progression, intolerable toxicity, or patient refusal. Objective response rates primary objective. Progression-free survival, overall survival, and safety are secondary objectives. The study will enroll a total of 50 patients.
- Conditions
- Recurrent Cervical Carcinoma, Metastatic Cervical Carcinoma, Persistent Cervical Carcinoma, Radiotherapy, Immunotherapy, Anti-programmed Cell Death Receptor 1
- Being tested
- Tislelizumab plus radiotherapy
- 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.
Tislelizumab plus radiotherapyCombination product
During the period of radiotherapy, patients receiveTislelizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W). Tislelizumab 200mg q3W was administered for up to 35 cycles (up to approximately 2 years) after radiotherapy until disease progression or toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Patients with recurrent cervical cancer | Experimental | Patients with recurrent, metastatic and persistent advanced cervical cancer Receives: Combination Product: Tislelizumab plus radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Overall survival is defined as the duration from date of enrollment to the date of death from any cause
Measured: 12 months
Secondary outcomes (3)
Progression-free survival (PFS)
PFS defined as the time the duration from date of enrollment to the first documented disease progression, or death due to any cause, whichever occurs first.
Measured: 12 months
Overall survival
Overall survival is defined as the duration from date of enrollment to the date of death from any cause
Measured: 24 months
Adverse Events
Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start27 Mar 2022
- Primary completion27 Mar 2023 (estimated)
- Study completion27 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Cervical CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310383
- Sponsor's protocol ID
- IMURADIO2
- Status last verified
- Apr 2022
- First submitted
- 26 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Immune Checkpoint Inhibitors Tislelizumab and Radiotherapy for Recurrent, Metastatic and Persistent Advanced Cervical Cancer: A Single-arm, Single-center, Phase 2 Clinical Study
- ClinicalTrials.gov ID
- NCT05310383
- Acronym / sponsor ID
- IMURADIO2
- Conditions
- Recurrent Cervical Carcinoma, Metastatic Cervical Carcinoma, Persistent Cervical Carcinoma, Radiotherapy, Immunotherapy, Anti-programmed Cell Death Receptor 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 27 Mar 2022 (actual)
- Primary completion
- 27 Mar 2023 (estimated)
- Study completion
- 27 Mar 2024 (estimated)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel plus bevacizumab for platinum-resistant recurrent epithelial ovarian cancer. Patients with platinum-resistant recurrent ovarian cancer who meet the inclusion criteria, and don't meet any of the exclusion criteria, are enrolled in the study. They will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. The total treatment periods are no more than 6 cycles. Treatment continue until disease progression, intolerable toxicity, or patient refusal. Objective response rates primary objective. Progression-free survival, overall survival, and safety are secondary objectives. The study will enroll a total of 50 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with recurrent cervical cancer | Experimental | Combination Product: Tislelizumab plus radiotherapyPatients with recurrent, metastatic and persistent advanced cervical cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient voluntarily participates and signs informed consent
- Aged 18 years of age or older
- Has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 within 7 days prior to the first dose of study treatment
- Has recurrent cervical cancer and controllable local treatment, indicating an indication for radiation therapy
- Willing to accept concurrent radiotherapy combined with Tislelizumab
Key exclusion criteria (8 listed)
- Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- Has a known history of Human Immunodeficiency Virus (HIV) infection，active Hepatitis virus infection and active tuberculosis (TB; Bacillus tuberculosis)
- Has known active central nervous system (CNS) metastases and/or uncontrolled, untreated carcinomatous meningitis with elevated intracranial pressure
- Has received a major surgery within 4 weeks prior to signing informed consent
- Not suitable for radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tislelizumab plus radiotherapyDuring the period of radiotherapy, patients receiveTislelizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W). Tislelizumab 200mg q3W was administered for up to 35 cycles (up to approximately 2 years) after radiotherapy until disease progression or toxicity. | Combination product | Patients with recurrent cervical cancer |
Primary outcome
Objective Response Rate
Time frame: 12 months
Overall survival is defined as the duration from date of enrollment to the date of death from any cause
3 secondary outcomes
Progression-free survival (PFS)
Time frame: 12 months
Overall survival
Time frame: 24 months
Adverse Events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Li, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab plus radiotherapy in people with Recurrent Cervical Carcinoma and Metastatic Cervical Carcinoma, run by Lei Li 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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Li, M.D. (86-139-1198-8831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2022; AzTrials last refreshed its copy on 26 Oct 2026.