Recurrent Cervical CarcinomaPhase 2NCT04188860
Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy
A Phase 2 study testing A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel in people with Recurrent Cervical Carcinoma and Persistent Advanced Cervical Carcinoma, run by Lei Li at 1 site in China.
Trial summary
For recurrent or persistent advanced cervical cancer patients, the first-line chemotherapy was based on platinum. However, if they were refractory to platinum-based chemotherapy, there were no other more effective medications or treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Recurrent Cervical Carcinoma, Persistent Advanced Cervical Carcinoma, Chemotherapy
- What is being tested?
- A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2019to 6 Mar 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female of 18-75 years old
- Eastern Cooperative Oncology Group score 0-1
- Pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma, with stage IA1 (with lymph-vascular space invasion) to IVB, which had accepted radical treatment for the purpose of cure
- Having accepted at least one regimen of platinum-based chemotherapy after the diagnosis of recurrent or persistent advanced cervical cancer, and having an interval of at least 4 weeks since fulfilling the last treatment regimen
- At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1
- Anticipative survival period of 3 months or more
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- Lab testing within reference ranges
- With appropriate contraception
- Provided consents of participating the trial
Who cannot join
- With brain metastasis
- With addiction to psychiatric medications or with mental disorders
- With following history and/or complications: autoimmune disease; systematic utilization of corticosteroids (with equivalent of prednison of > 10 mg/day) or other immunosuppressors within 14 days; utilization of antitumor vaccine or other immunostimulation treatment with 3 months; exposure to PD-1 antibody, or PD-L1 antibody, or PD-L2 antibody, or cytotoxic T lymphocyte-associated antigen-4 antibody; history of other malignancies; pulmonary tuberculosis; interstitial pneumonia or related history; active hepatitis; positive testing of human immunodeficiency
- With adverse effects more than Common Terminology Criteria for Adverse Events grade 1 (except for alopecia), which caused by previous anti-tumor treatment
- With infective disease which need systematic treatment within 14 days
- With severe open trauma, fracture or major surgery with past 4 weeks
- With potential allergy or intolerance to study regimens
- Not eligible for the study judged by researchers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-PD-1 Antibody Camrelizumab Combined With Albumin-bound Paclitaxel for Recurrent and Persistent Advanced Cervical Cancer Refractory to Platinum-based Chemotherapy: A Single Arm, Single Center, Open, Phase II Trial
For recurrent or persistent advanced cervical cancer patients, the first-line chemotherapy was based on platinum. However, if they were refractory to platinum-based chemotherapy, there were no other more effective medications or treatment. The marketing of anti-PD-1 antibody has provided an opportunity of curative management. This single arm, open, phase II trial would recruit 34 eligible patients. A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for first 9 patients. If at least total 2 patients achieved complete or partial remission, or at least total 6 patients achieved complete or partial remission or stable disease, the same regimen would be given for rest patients. The primary end is overall response rate (ORR). The second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. A molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.
- Conditions
- Recurrent Cervical Carcinoma, Persistent Advanced Cervical Carcinoma, Chemotherapy, Anti-PD-1 Antibody, Immunotherapy
- Being tested
- A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel
- 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.
A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxelDrug
A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for all patients:
- Camrelizumab: 200 mg every time, every 3 weeks, which would be sustained until the appearance of disease progression on intolerable adverse events, and no more than 24 months
- Albumin-bound paclitaxel: 200-300 mg every time, every 3 weeks, no more than 6 courses
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | The patients in the study group would accept the treatment of a combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel. Receives: Drug: A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
The rates of complete and partial remission
Measured: One year
Secondary outcomes (5)
Progression-free survival
The length of time during and after the treatment of the cancer, that a patient lives with the disease but it does not get worse
Measured: One year
Overall survival
The length of time from either the date of diagnosis or the start of treatment for the cancer, that patients diagnosed with the disease are still alive.
Measured: One year
Disease control rate
The rates of complete and partial remission, and stable disease
Measured: One year
Remission duration
The duration of complete and partial remission
Measured: One years
Adverse event rates
The rates of adverse events judged by Common Terminology Criteria for Adverse Events
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start6 Dec 2019
- Primary completion6 Jan 2022
- Study completion6 Mar 2022
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
- 34 participants (actual)
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
- NCT04188860
- Sponsor's protocol ID
- REPACC-2
- Status last verified
- Mar 2022
- First submitted
- 4 Dec 2019
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data will be available by public reports.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-PD-1 Antibody Camrelizumab Combined With Albumin-bound Paclitaxel for Recurrent and Persistent Advanced Cervical Cancer Refractory to Platinum-based Chemotherapy: A Single Arm, Single Center, Open, Phase II Trial
- ClinicalTrials.gov ID
- NCT04188860
- Acronym / sponsor ID
- REPACC-2
- Conditions
- Recurrent Cervical Carcinoma, Persistent Advanced Cervical Carcinoma, Chemotherapy, Anti-PD-1 Antibody, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 6 Mar 2022 (actual)
- First posted
- 6 Dec 2019 (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.
For recurrent or persistent advanced cervical cancer patients, the first-line chemotherapy was based on platinum. However, if they were refractory to platinum-based chemotherapy, there were no other more effective medications or treatment. The marketing of anti-PD-1 antibody has provided an opportunity of curative management. This single arm, open, phase II trial would recruit 34 eligible patients. A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for first 9 patients. If at least total 2 patients achieved complete or partial remission, or at least total 6 patients achieved complete or partial remission or stable disease, the same regimen would be given for rest patients. The primary end is overall response rate (ORR). The second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. A molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxelThe patients in the study group would accept the treatment of a combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female of 18-75 years old
- Eastern Cooperative Oncology Group score 0-1
- Pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma, with stage IA1 (with lymph-vascular space invasion) to IVB, which had accepted radical treatment for the purpose of cure
- Having accepted at least one regimen of platinum-based chemotherapy after the diagnosis of recurrent or persistent advanced cervical cancer, and having an interval of at least 4 weeks since fulfilling the last treatment regimen
- At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1
Key exclusion criteria (8 listed)
- With brain metastasis
- With addiction to psychiatric medications or with mental disorders
- With following history and/or complications: autoimmune disease; systematic utilization of corticosteroids (with equivalent of prednison of > 10 mg/day) or other immunosuppressors within 14 days; utilization of antitumor vaccine or other immunostimulation treatment with 3 months; exposure to PD-1 antibody, or PD-L1 antibody, or PD-L2 antibody, or cytotoxic T lymphocyte-associated antigen-4 antibody; history of other malignancies; pulmonary tuberculosis; interstitial pneumonia or related history; active hepatitis; positive testing of human immunodeficiency
- With adverse effects more than Common Terminology Criteria for Adverse Events grade 1 (except for alopecia), which caused by previous anti-tumor treatment
- With infective disease which need systematic treatment within 14 days
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 |
|---|---|---|
| A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxelA combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for all patients: * Camrelizumab: 200 mg every time, every 3 weeks, which would be sustained until the appearance of disease progression on intolerable adverse events, and no more than 24 months * Albumin-bound paclitaxel: 200-300 mg every time, every 3 weeks, no more than 6 courses | Drug | Study group |
Primary outcome
Overall response rate
Time frame: One year
The rates of complete and partial remission
5 secondary outcomes
Progression-free survival
Time frame: One year
Overall survival
Time frame: One year
Disease control rate
Time frame: One year
Remission duration
Time frame: One years
Adverse event rates
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: Yes. The individual participant data will be available by public reports.
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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 A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel in people with Recurrent Cervical Carcinoma and Persistent Advanced 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 9 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: finished, as of the sponsor's last update on 15 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall response rate (time frame: One 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 15 Mar 2022.