Locally Advanced Cervical CancerPhase 2NCT06237257
A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer
A Phase 2 study testing SHR-1316, Cisplatin Injection/Carboplatin Injection and External Beam Radiotherapy (EBRT)/Brachytherapy in people with Locally Advanced Cervical Cancer, run by Shanghai Shengdi Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The Primary purpose of this study is to evaluate the safety of SHR-1316 plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. The second purpose of this study is to evaluate the efficacy and PK traits; The exploratory study is to explore the biomarker 、immunogenicity and so on . Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer
- What is being tested?
- SHR-1316, Cisplatin Injection/Carboplatin Injection and External Beam Radiotherapy (EBRT)/Brachytherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2024to Jan 2025
- 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
- Able and willing to provide a written informed consent
- Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix；
- Has locally advanced cervical cancer；
- At least one measurable lesion ( RECIST version 1.1)；
- Investigator assess it is suitable for concurrent chemoradiotherapy;
- Has provided a tissue sample from tumor lesion;
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- Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- BMI≥18.5kg/m2；
- Female participants of childbearing potential must agree to use highly effective contraception during the treatment period and for at least 7 months after the last dose of drug，Female participants' HCG must be negative within 3 days prior to enrollment and must be non-lactating.
Who cannot join
- Histopathologically confirmed small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma of the cervix；
- The presence of distant metastatic disease was confirmed by pathology or imaging;
- has previously undergone hysterectomy (including subtotal hysterectomy) or plan to undergo hysterectomy for cervical cancer, or plan to adopt fertility preservation therapy;
- In the investigator's judgment, there is a disease (such as severe diabetes, neurological or psychiatric illness, etc.) or any other condition that seriously endangers the subject's safety, confuses the study results, or interferes with the subject's ability to complete the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200433
About this study
The Primary purpose of this study is to evaluate the safety of SHR-1316 plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer.
The second purpose of this study is to evaluate the efficacy and PK traits; The exploratory study is to explore the biomarker 、immunogenicity and so on .
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- SHR-1316, Cisplatin Injection/Carboplatin Injection, External Beam Radiotherapy (EBRT)/Brachytherapy, Paclitaxel Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1316Biological
SHR-1316（Adebrelimab Injection）
Cisplatin Injection/Carboplatin InjectionDrug
Cisplatin Injection/Carboplatin Injection
External Beam Radiotherapy (EBRT)/BrachytherapyRadiation
External Beam Radiotherapy (EBRT)/Brachytherapy
Paclitaxel InjectionDrug
Paclitaxel Injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1316 plus concurrent chemoradiotherapy | Experimental | Not described Receives: Biological: SHR-1316; Drug: Cisplatin Injection/Carboplatin Injection; Radiation: External Beam Radiotherapy (EBRT)/Brachytherapy; Drug: Paclitaxel Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, incidence and grade of drug-related adverse events of grade 3 and above
Measured: Up to approximately 24 months
Secondary outcomes (17)
Adverse events (AEs) include incidence, grade (judged according to NCI-CTCAE V5.0 standards), duration and correlation with study drugs
Measured: Up to approximately 30 months
Rate of Suspension and Discontinuation Due to an Adverse Event correlation with study drug
Measured: Up to approximately 30 months
Objective Response Rate(ORR)
judged based on RECIST 1.1 criteria according to Investigator's assessment
Measured: Up to approximately 60 months
Duration of response (DoR)
judged based on RECIST 1.1 criteria according to Investigator's assessment
Measured: Up to approximately 60 months
Progression free survival (PFS)
judged based on RECIST 1.1 criteria according to Investigator's assessment
Measured: Up to approximately 60 months
Overall Survival (OS)
judged based on RECIST 1.1 criteria according to Investigator's assessment
Measured: Up to approximately 60 months
2-year Progression free survival
judged based on RECIST 1.1 criteria according to Investigator's assessment
Measured: Up to approximately 24 months
3-year Overall Survival
judged based on RECIST 1.1 criteria according to Investigator's assessment
Measured: Up to approximately 36 months
12-week Complete Response
judged based on RECIST 1.1 criteria according to Investigator's assessment
Measured: Up to approximately 4 months
PK traits of SHR-1316: Cmax
Measured: Up to approximately 24 months
PK traits of SHR-1316: Tmax
Measured: Up to approximately 24 months
PK traits of SHR-1316: AUC0-t
Measured: Up to approximately 24 months
PK traits of SHR-1316: AUC0-∞
Measured: Up to approximately 24 months
PK traits of SHR-1316: t1/2
Measured: Up to approximately 24 months
PK traits of SHR-1316: CL
Measured: Up to approximately 24 months
PK traits of SHR-1316: Vss
Measured: Up to approximately 24 months
Serum concentration of SHR-1316 at each planned blood collection time point
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start20 Mar 2024
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (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.
- 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Shengdi Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237257
- Sponsor's protocol ID
- SHR-1316-202
- Status last verified
- Apr 2024
- First submitted
- 23 Jan 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT06237257
- Acronym / sponsor ID
- SHR-1316-202
- Conditions
- Locally Advanced Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Shanghai Shengdi Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 1 Feb 2024 (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.
The Primary purpose of this study is to evaluate the safety of SHR-1316 plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer.
The second purpose of this study is to evaluate the efficacy and PK traits; The exploratory study is to explore the biomarker 、immunogenicity and so on .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1316 plus concurrent chemoradiotherapy | Experimental | Biological: SHR-1316, Drug: Cisplatin Injection/Carboplatin Injection, Radiation: External Beam Radiotherapy (EBRT)/Brachytherapy, Drug: Paclitaxel Injection |
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)
- Able and willing to provide a written informed consent
- Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix；
- Has locally advanced cervical cancer；
- At least one measurable lesion ( RECIST version 1.1)；
- Investigator assess it is suitable for concurrent chemoradiotherapy;
Key exclusion criteria (4 listed)
- Histopathologically confirmed small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma of the cervix；
- The presence of distant metastatic disease was confirmed by pathology or imaging;
- has previously undergone hysterectomy (including subtotal hysterectomy) or plan to undergo hysterectomy for cervical cancer, or plan to adopt fertility preservation therapy;
- In the investigator's judgment, there is a disease (such as severe diabetes, neurological or psychiatric illness, etc.) or any other condition that seriously endangers the subject's safety, confuses the study results, or interferes with the subject's ability to complete the study.
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 |
|---|---|---|
| SHR-1316SHR-1316（Adebrelimab Injection） | Biological | SHR-1316 plus concurrent chemoradiotherapy |
| Cisplatin Injection/Carboplatin InjectionCisplatin Injection/Carboplatin Injection | Drug | SHR-1316 plus concurrent chemoradiotherapy |
| External Beam Radiotherapy (EBRT)/BrachytherapyExternal Beam Radiotherapy (EBRT)/Brachytherapy | Radiation | SHR-1316 plus concurrent chemoradiotherapy |
| Paclitaxel InjectionPaclitaxel Injection. | Drug | SHR-1316 plus concurrent chemoradiotherapy |
Primary outcome
Type, incidence and grade of drug-related adverse events of grade 3 and above
Time frame: Up to approximately 24 months
17 secondary outcomes
Adverse events (AEs) include incidence, grade (judged according to NCI-CTCAE V5.0 standards), duration and correlation with study drugs
Time frame: Up to approximately 30 months
Rate of Suspension and Discontinuation Due to an Adverse Event correlation with study drug
Time frame: Up to approximately 30 months
Objective Response Rate(ORR)
Time frame: Up to approximately 60 months
Duration of response (DoR)
Time frame: Up to approximately 60 months
Progression free survival (PFS)
Time frame: Up to approximately 60 months
Overall Survival (OS)
Time frame: Up to approximately 60 months
2-year Progression free survival
Time frame: Up to approximately 24 months
3-year Overall Survival
Time frame: Up to approximately 36 months
12-week Complete Response
Time frame: Up to approximately 4 months
PK traits of SHR-1316: Cmax
Time frame: Up to approximately 24 months
PK traits of SHR-1316: Tmax
Time frame: Up to approximately 24 months
PK traits of SHR-1316: AUC0-t
Time frame: Up to approximately 24 months
PK traits of SHR-1316: AUC0-∞
Time frame: Up to approximately 24 months
PK traits of SHR-1316: t1/2
Time frame: Up to approximately 24 months
PK traits of SHR-1316: CL
Time frame: Up to approximately 24 months
PK traits of SHR-1316: Vss
Time frame: Up to approximately 24 months
Serum concentration of SHR-1316 at each planned blood collection time point
Time frame: Up to approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SHR-1316, Cisplatin Injection/Carboplatin Injection and External Beam Radiotherapy (EBRT)/Brachytherapy in people with Locally Advanced Cervical Cancer, run by Shanghai Shengdi Pharmaceutical Co., Ltd 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 4 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 24 Dec 2024. 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?
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?
Type, incidence and grade of drug-related adverse events of grade 3 and above (time frame: Up to approximately 24 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 24 Dec 2024.