Locally Advanced Cervical CancerPhase 2NCT04884906
Camrelizumab Combined With Radiotherapy and Chemotherapy for the Treatment of Recurrent or Metastatic Cervical Cancer
A Phase 2 study testing Camrelizumab, radiotherapy and Albumin Paclitaxel in people with Locally Advanced Cervical Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
To evaluate the effectiveness and safety of camrelizumab combined with radiotherapy and chemotherapy for recurrent or metastatic cervical cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Cervical Cancer
- What is being tested?
- Camrelizumab, radiotherapy and Albumin Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 1 Nov 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old and ≤75 years old;
- ECOG score 0-1 level;
- Cervical cancer diagnosed pathologically, cervical cancer that has recurred or metastasized after at least first-line chemotherapy or surgery;
- Genetic testing: PD-L1≥1%;
- The expected survival period is ≥6 months;
- The functional level of major organs must meet the following requirements:
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- Blood routine: ANC≥1.5×109/L; PLT≥90×109/L; Hb≥90 g/L; Blood biochemistry: TBIL≤2.5×ULN; ALT and AST≤1.5×ULN; BUN and Cr ≤1.5×ULN;
- Heart color Doppler ultrasound: LVEF≥50%;
- 12-lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method <450 ms for males and <470 ms for females;
- No blood transfusion within 2 weeks before screening;
- For female subjects who have not undergone menopause or have not undergone surgical sterilization, during the treatment period and at least 7 months after the last administration in the study treatment, agree to abstain from sex or use an effective method of contraception;
- Volunteer to join the study, sign informed consent, have good compliance and are willing to cooperate with follow-up.
Who cannot join
- Have received previous anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors;
- Previously received camrelizumab or other PD-1/PD-L1 treatments and cannot be included in the group; the subject is known to have been exposed to macromolecular protein preparations, or is known to be against any carrelizumab, or Subjects are allergic to the chemotherapeutic ingredients used during neoadjuvant treatment;
- At the same time receive anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy;
- In the 4 weeks before randomization, have received major surgical operations not related to cervical cancer, or the subject has not fully recovered from such surgical operations.
- Those who are known to have a history of allergies to the drug components of this program;
- A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
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- Have ever suffered from any heart disease, including: (1) angina pectoris; (2) arrhythmia requiring medical treatment or clinical significance; (3) myocardial infarction; (4) heart failure; (5) any investigator Other heart diseases judged to be unsuitable for participating in this test.
- Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period.
- According to the judgment of the investigator, there are concomitant diseases (including but not limited to high blood pressure, severe diabetes, active infection, thyroid disease, etc.) that seriously endanger the safety of the patient or affect the completion of the study;
- Inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect the administration and absorption of drugs.
- The researcher believes that the subject is not suitable for participating in any other situations in this research.
Trial locations and contacts
1 site in 1 country.
Chen contact
China1 site, 1 recruiting
- Recruiting
TianjinCIH
Tianjin, Tianjin Municipality
Chen Zhongjie, 18622228638, 13702096685@139.com
About this study
Official title: A Single-arm, Single-center, Open, Prospective Phase II Clinical Study of Camrelizumab Combined With Radiotherapy and Chemotherapy for the Treatment of Recurrent or Metastatic Cervical Cancer
To evaluate the effectiveness and safety of camrelizumab combined with radiotherapy and chemotherapy for recurrent or metastatic cervical cancer
Read the detailed description
This study is a single-arm, single-center, open, prospective phase II clinical study, the main purpose of which is to evaluate the effectiveness and safety of camrelizumab combined with radiotherapy and chemotherapy for recurrent or metastatic cervical cancer.
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- Camrelizumab, radiotherapy, Albumin Paclitaxel, Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabBiological
200mg/m2, iv, d1, Q3W, a total of 6 cycles
radiotherapyRadiation
1.8-2.15Gy/time (radiotherapy started on the 8th day of camrelizumab treatment), a total of 28 times (5 times a week), a total of 50.4-60.2Gy.
Albumin PaclitaxelDrug
260mg/m2, iv, d1, Q3W, a total of 6 cycles
CisplatinDrug
80-120mg/m2, iv, d1-3, Q3W, a total of 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab combined with radiotherapy and chemotherapy | Experimental | Not described Receives: Biological: Camrelizumab; Radiation: radiotherapy; Drug: Albumin Paclitaxel; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The objective remission rate refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission and partial remission
Measured: 2 year
Secondary outcomes (5)
Progression-free survival（PFS）
The period of time between when a patient with neoplastic disease receives treatment and when the disease progresses or death from any cause occurs
Measured: 2 year
Overall survival（OS）
The time from the patient's confirmation of the disease to death due to any cause
Measured: 2 year
Disease control rate（DCR）
Refers to the proportion of patients whose tumors have shrunk or stabilized for a certain period of time, including complete remission (CR), partial remission (PR) and stable (SD) cases
Measured: 2 year
Adverse reaction rate
Harmful and unrelated reactions that occur when normal doses of drugs are used to prevent, diagnose, treat diseases or regulate physiological functions
Measured: 2 year
Patient quality of life
Comprehensively evaluate the pros and cons of life by filling in the questionnaire
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Nov 2020
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Cervical CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884906
- Sponsor's protocol ID
- E20210044
- Status last verified
- May 2021
- First submitted
- 11 May 2021
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center, Open, Prospective Phase II Clinical Study of Camrelizumab Combined With Radiotherapy and Chemotherapy for the Treatment of Recurrent or Metastatic Cervical Cancer
- ClinicalTrials.gov ID
- NCT04884906
- Acronym / sponsor ID
- E20210044
- Conditions
- Locally Advanced Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 13 May 2021 (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.
To evaluate the effectiveness and safety of camrelizumab combined with radiotherapy and chemotherapy for recurrent or metastatic cervical cancer
Detailed description
This study is a single-arm, single-center, open, prospective phase II clinical study, the main purpose of which is to evaluate the effectiveness and safety of camrelizumab combined with radiotherapy and chemotherapy for recurrent or metastatic cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab combined with radiotherapy and chemotherapy | Experimental | Biological: Camrelizumab, Radiation: radiotherapy, Drug: Albumin Paclitaxel, Drug: Cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years old and ≤75 years old;
- ECOG score 0-1 level;
- Cervical cancer diagnosed pathologically, cervical cancer that has recurred or metastasized after at least first-line chemotherapy or surgery;
- Genetic testing: PD-L1≥1%;
- The expected survival period is ≥6 months;
Key exclusion criteria (11 listed)
- Have received previous anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors;
- Previously received camrelizumab or other PD-1/PD-L1 treatments and cannot be included in the group; the subject is known to have been exposed to macromolecular protein preparations, or is known to be against any carrelizumab, or Subjects are allergic to the chemotherapeutic ingredients used during neoadjuvant treatment;
- At the same time receive anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy;
- In the 4 weeks before randomization, have received major surgical operations not related to cervical cancer, or the subject has not fully recovered from such surgical operations.
- Those who are known to have a history of allergies to the drug components of this program;
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 |
|---|---|---|
| Camrelizumab200mg/m2, iv, d1, Q3W, a total of 6 cycles | Biological | Camrelizumab combined with radiotherapy and chemotherapy |
| radiotherapy1.8-2.15Gy/time (radiotherapy started on the 8th day of camrelizumab treatment), a total of 28 times (5 times a week), a total of 50.4-60.2Gy. | Radiation | Camrelizumab combined with radiotherapy and chemotherapy |
| Albumin Paclitaxel260mg/m2, iv, d1, Q3W, a total of 6 cycles | Drug | Camrelizumab combined with radiotherapy and chemotherapy |
| Cisplatin80-120mg/m2, iv, d1-3, Q3W, a total of 6 cycles | Drug | Camrelizumab combined with radiotherapy and chemotherapy |
Primary outcome
Objective response rate (ORR)
Time frame: 2 year
The objective remission rate refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission and partial remission
5 secondary outcomes
Progression-free survival（PFS）
Time frame: 2 year
Overall survival（OS）
Time frame: 2 year
Disease control rate（DCR）
Time frame: 2 year
Adverse reaction rate
Time frame: 2 year
Patient quality of life
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Individual participant dataSharing planned: No
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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.
Chen contact
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 Camrelizumab, radiotherapy and Albumin Paclitaxel in people with Locally Advanced Cervical Cancer, run by Tianjin Medical University Cancer Institute and Hospital 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 12 inclusion and 11 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 13 May 2021. 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 Chen, 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: 2 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 13 May 2021.