Cervical CancerNCT05863260
Tislelizumab Combing Chemoradiotherapy in Recurrent Cervical Cancer
An observational study of Cervical Cancer and Immune Checkpoint Inhibitor, run by Fudan University at 1 site in China.
Trial summary
Tislelizumab combined with chemoradiotherapy in the treatment of recurrent/ metastasis cervical cancer: a single arm,single center， phase ii and observational clinical study Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer, Immune Checkpoint Inhibitor, Chemoradiotherapy
- What is being tested?
- Treatment Group
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2020to 31 Dec 2024
- Phase
- Observational
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with recurrent or metastatic cervical cancer after initial standard treatment (including radical surgery or radical radiotherapy), the lesions are located out of the field of previous radiotherapy, with no more than 5 recurrent or metastatic foci, and the radiotherapy is feasible according to the evaluation of radiotherapy physician; and at least 1 lesion (without previous radiotherapy) meets the target lesion standard of RECIST 1.1
Who may be able to join
- For patients with recurrent or metastatic cervical cancer after initial standard treatment (including radical surgery or radical radiotherapy), the lesions are located out of the field of previous radiotherapy, with no more than 5 recurrent or metastatic foci, and the radiotherapy is feasible according to the evaluation of radiotherapy physician; and at least 1 lesion (without previous radiotherapy) meets the target lesion standard of RECIST 1.1;
- Cervical adenocarcinoma, squamous cell carcinoma or adenosquamous cell carcinoma confirmed by previous histology;
- Surgical resection is not recommended for recurrent lesions, or patients choose not to accept surgery voluntarily;
- The researchers evaluated the suitability of radiotherapy
- ECoG 0-1; life expectancy > 6 months;
- Aged 18-70 years;
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- No serious allergic history;
- Hemoglobin > 100 g / L, WBC > 3.5 * 10 ^ 9 / L, neutrophils > 1.5 * 10 ^ 9 / L, platelets > 100 * 10 ^ 9 / L, Cr < 1.5 * normal upper limit, TB < 2.5 * normal upper limit, AST and Al < 2.5 * normal upper limit, AKP < 2.5 * normal upper limit;
- Ability to sign informed consent.
Who cannot join
- Histologically, small cell (neuroendocrine) cervical cancer, mucinous adenocarcinoma, carcinosarcoma and other pathological types were confirmed;
- Primary malignant tumor with activity in other parts, except for the following:
- Those who have been cured have no known active disease at least 5 years before the first IP administration, and the potential risk of recurrence is low;
- Fully treat non melanoma skin cancer or malignant nevus without disease signs;
- Fully treated carcinoma in situ, no signs of disease.
- The recurrent lesions have received chemotherapy, radiotherapy or other anti-tumor treatment;
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- Bone metastasis;
- Brain metastasis;
- Pregnant or lactating patients;
- In the past, there was abnormal thyroid function, and under the condition of drug treatment, thyroid function could not be maintained in the normal range;
- Diagnosis of immune deficiency or treatment with chronic systemic steroids (doses more than 10 mg per day of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before enrollment;
- Patients with active autoimmune diseases need systemic treatment in the past 2 years;
- A history of (noninfectious) pneumonia requiring steroids or current pneumonia;
- There are active infections that need systematic treatment;
- Known history of human immunodeficiency virus (HIV) infection;
- Known history of hepatitis B or known active hepatitis C virus infection;
- Known history of active tuberculosis (TB);
- Uncontrolled comorbidities, including but not limited to: persistent or active infection, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled diabetes, uncontrolled arrhythmias, active interstitial lung disease (ILD), severe chronic gastrointestinal disease with diarrhea, or may limit compliance with study requirements, leading to AE Mental / social problems that significantly increase or affect the ability of subjects to provide written informed consent;
- 14 days before admission, the operation was too large and had not recovered;
- Participate in other clinical trials at present or within 28 days before selection;
- Any indications, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-PD-L2 antibodies or therapeutic anti-cancer vaccines, were treated by immunomediated therapy prior to the study;
- Any synchronous chemotherapy, research drug, biological product, or hormone therapy used to treat tumors. Hormone therapy can also be used to treat non tumor related diseases (e.g., hormone replacement therapy);
- Allogeneic tissue / solid organ transplantation was carried out.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
JUN ZHU, M.D., 8613564972482, dragonzld@163.com
About this study
Official title: Tislelizumab (Anti-PD-1) Combined With Definitive Chemoradiotherapy in Recurrent Cervical Cancer (PILOT-2020-511): a Single-arm, Phase 2 Trial
Tislelizumab combined with chemoradiotherapy in the treatment of recurrent/ metastasis cervical cancer: a single arm,single center， phase ii and observational clinical study
Read the detailed description
Tislelizumab combined with chemoradiotherapy in the treatment of recurrent/ metastasis cervical cancer: a single arm,single center， phase ii and observational clinical study
- Being tested
- Treatment Group
- 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.
Treatment GroupDrug
Treatment Group
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Paclitaxel 135mg / m2d1 + cisplatin 60mg / m2d1 (cisplatin resistance or cisplatin intolerance changed to carboplatin AUC = 5d1), q3w × 4 and Standard IMRT and radiotherapyTislelizumab 200mg, IV, q3w, the day before radiotherapy Receives: Drug: Treatment Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate
Measured: 1 year
Secondary outcomes (2)
1-year PFS
1-year PFS
Measured: 1 year
1-year OS
1-year OS
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start9 Nov 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863260
- Sponsor's protocol ID
- PILOT-2020-511
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 18 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tislelizumab (Anti-PD-1) Combined With Definitive Chemoradiotherapy in Recurrent Cervical Cancer (PILOT-2020-511): a Single-arm, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT05863260
- Acronym / sponsor ID
- PILOT-2020-511
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 May 2023 (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.
Tislelizumab combined with chemoradiotherapy in the treatment of recurrent/ metastasis cervical cancer: a single arm,single center， phase ii and observational clinical study
Detailed description
Tislelizumab combined with chemoradiotherapy in the treatment of recurrent/ metastasis cervical cancer: a single arm,single center， phase ii and observational clinical study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Drug: Treatment GroupPaclitaxel 135mg / m2d1 + cisplatin 60mg / m2d1 (cisplatin resistance or cisplatin intolerance changed to carboplatin AUC = 5d1), q3w × 4 and Standard IMRT and radiotherapyTislelizumab 200mg, IV, q3w, the day before radiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recurrent or metastatic cervical cancer after initial standard treatment (including radical surgery or radical radiotherapy), the lesions are located out of the field of previous radiotherapy, with no more than 5 recurrent or metastatic foci, and the radiotherapy is feasible according to the evaluation of radiotherapy physician; and at least 1 lesion (without previous radiotherapy) meets the target lesion standard of RECIST 1.1
Key inclusion criteria (9 listed)
- For patients with recurrent or metastatic cervical cancer after initial standard treatment (including radical surgery or radical radiotherapy), the lesions are located out of the field of previous radiotherapy, with no more than 5 recurrent or metastatic foci, and the radiotherapy is feasible according to the evaluation of radiotherapy physician; and at least 1 lesion (without previous radiotherapy) meets the target lesion standard of RECIST 1.1;
- Cervical adenocarcinoma, squamous cell carcinoma or adenosquamous cell carcinoma confirmed by previous histology;
- Surgical resection is not recommended for recurrent lesions, or patients choose not to accept surgery voluntarily;
- The researchers evaluated the suitability of radiotherapy
- ECoG 0-1; life expectancy > 6 months;
Key exclusion criteria (23 listed)
- Histologically, small cell (neuroendocrine) cervical cancer, mucinous adenocarcinoma, carcinosarcoma and other pathological types were confirmed;
- Primary malignant tumor with activity in other parts, except for the following:
- Those who have been cured have no known active disease at least 5 years before the first IP administration, and the potential risk of recurrence is low;
- Fully treat non melanoma skin cancer or malignant nevus without disease signs;
- Fully treated carcinoma in situ, no signs of disease.
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 |
|---|---|---|
| Treatment GroupTreatment Group | Drug | Intervention |
Primary outcome
ORR
Time frame: 1 year
Objective response rate
2 secondary outcomes
1-year PFS
Time frame: 1 year
1-year OS
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Immune Checkpoint Inhibitor, run by Fudan 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 9 inclusion and 23 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 18 May 2023. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 1 year). 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 18 May 2023.