Advanced Cervical CancerPhase 3NCT07168200
A Phase III Clinical Study of Adebrelimab Combined With Concurrent Chemoradiotherapy Versus Placebo Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced Cervical Cancer
A Phase 3 study testing SHR-1316 Injection, Cisplatin Injection and Carboplatin Injection in people with Advanced Cervical Cancer, run by Shanghai Shengdi Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This study aims to evaluate the efficacy of Adebrelimab plus concurrent chemoradiotherapy compared with placebo plus concurrent chemoradiotherapy for the treatment of locally advanced cervical cancer by evaluating progression-free survival (PFS). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Advanced Cervical Cancer
- What is being tested?
- SHR-1316 Injection, Cisplatin Injection and Carboplatin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 720 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2025to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Participate in the study voluntarily, sign the informed consent form.
- Subjects were able to provide primary or metastatic cancer samples.
- At least one measurable lesion.
- Expected survival > 3 months.
- ECOG 0 ~ 1.
- With adequate organ functions.
Who cannot join
- Pathologically or radiologically confirmed presence of distant metastatic disease, including lymph nodes above the first lumbar vertebra (L1) (cephalad) or in the inguinal region.
- Administering live vaccines within 4 weeks before enrollment or during planned study treatment.
- Participants who received immunosuppressive therapy within 4 weeks before enrolment.
- For participants who are receiving thrombolytic/anticoagulant therapy, prophylactic anticoagulant therapy is allowed.
- Participants who have had other uncured malignant tumors in the past (within 5 years) or concurrently have had other uncured malignant tumors, excluding cured basal cell carcinoma of the skin and carcinoma in situ.
- Known allergy to the investigational drug or any of its excipients; or severe allergic reaction to other monoclonal antibodies.
- Pregnant or breastfeeding women.
- According to the investigator's judgment, there are diseases or any other conditions that may seriously endanger the safety of the subjects, may confound the research results, or affect the subjects' ability to complete the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xiaohua Wu, +86-021-64175590, wu.xh@fudan.edu.cn
Xiaohua Wu
About this study
Official title: A Randomized, Controlled, Double-blind, Multicenter Phase III Clinical Study of Adebrelimab Combined With Concurrent Chemoradiotherapy Versus Placebo Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced Cervical Cancer
This study aims to evaluate the efficacy of Adebrelimab plus concurrent chemoradiotherapy compared with placebo plus concurrent chemoradiotherapy for the treatment of locally advanced cervical cancer by evaluating progression-free survival (PFS).
- Conditions
- Advanced Cervical Cancer
- Being tested
- SHR-1316 Injection, Cisplatin Injection, Carboplatin Injection, Paclitaxel Injection, SHR-1316 Placebo Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1316 InjectionDrug
SHR-1316 injection.
Cisplatin InjectionDrug
Cisplatin injection.
Carboplatin InjectionDrug
Carboplatin injection.
Paclitaxel InjectionDrug
Paclitaxel injection.
SHR-1316 Placebo InjectionDrug
SHR-1316 placebo injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1316 Group | Experimental | Not described Receives: Drug: SHR-1316 Injection; Drug: Cisplatin Injection; Drug: Carboplatin Injection; Drug: Paclitaxel Injection |
| SHR-1316 Placebo Group | Placebo comparator | Not described Receives: Drug: Cisplatin Injection; Drug: Carboplatin Injection; Drug: Paclitaxel Injection; Drug: SHR-1316 Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: Up to approximately 36 months.
Secondary outcomes (10)
Overall survival (OS)
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up.
Measured: Up to approximately 60 months.
3-year overall survival (OS) rate
OS rate within 3 years.
Measured: Up to approximately 60 months.
2-year progression-free survival (PFS)
PFS within 2 years.
Measured: Up to approximately 24 months.
Objective Response Rate (ORR)
Measured: Up to approximately 36 months.
Duration of response (DoR)
Measured: Up to approximately 60 months.
Local recurrence rate
Measured: Up to approximately 36 months.
Distant metastasis rate
Measured: Up to approximately 60 months.
The second disease progression assessed by the investigator
Measured: Up to approximately 60 months.
Adverse events (AEs) including incidence and grade correlation with study drugs
Measured: Up to approximately 60 months.
Rate of suspension and discontinuation due to an adverse event correlation with study drugs
Measured: Up to approximately 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start17 Oct 2025
- Primary completionApr 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 720 participants (estimated)
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
- NCT07168200
- Sponsor's protocol ID
- SHR-1316-305
- Status last verified
- Apr 2026
- First submitted
- 4 Sep 2025
- Last updated
- 15 Apr 2026
- 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 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-blind, Multicenter Phase III Clinical Study of Adebrelimab Combined With Concurrent Chemoradiotherapy Versus Placebo Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT07168200
- Acronym / sponsor ID
- SHR-1316-305
- Conditions
- Advanced Cervical Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Shanghai Shengdi Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Sep 2025 (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 aims to evaluate the efficacy of Adebrelimab plus concurrent chemoradiotherapy compared with placebo plus concurrent chemoradiotherapy for the treatment of locally advanced cervical cancer by evaluating progression-free survival (PFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-1316 Group | Experimental | Drug: SHR-1316 Injection, Drug: Cisplatin Injection, Drug: Carboplatin Injection, Drug: Paclitaxel Injection |
| SHR-1316 Placebo Group | Placebo comparator | Drug: Cisplatin Injection, Drug: Carboplatin Injection, Drug: Paclitaxel Injection, Drug: SHR-1316 Placebo Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participate in the study voluntarily, sign the informed consent form.
- Subjects were able to provide primary or metastatic cancer samples.
- At least one measurable lesion.
- Expected survival > 3 months.
- ECOG 0 ~ 1.
Key exclusion criteria (8 listed)
- Pathologically or radiologically confirmed presence of distant metastatic disease, including lymph nodes above the first lumbar vertebra (L1) (cephalad) or in the inguinal region.
- Administering live vaccines within 4 weeks before enrollment or during planned study treatment.
- Participants who received immunosuppressive therapy within 4 weeks before enrolment.
- For participants who are receiving thrombolytic/anticoagulant therapy, prophylactic anticoagulant therapy is allowed.
- Participants who have had other uncured malignant tumors in the past (within 5 years) or concurrently have had other uncured malignant tumors, excluding cured basal cell carcinoma of the skin and carcinoma in situ.
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-1316 InjectionSHR-1316 injection. | Drug | SHR-1316 Group |
| Cisplatin InjectionCisplatin injection. | Drug | SHR-1316 Group, SHR-1316 Placebo Group |
| Carboplatin InjectionCarboplatin injection. | Drug | SHR-1316 Group, SHR-1316 Placebo Group |
| Paclitaxel InjectionPaclitaxel injection. | Drug | SHR-1316 Group, SHR-1316 Placebo Group |
| SHR-1316 Placebo InjectionSHR-1316 placebo injection. | Drug | SHR-1316 Placebo Group |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to approximately 36 months.
10 secondary outcomes
Overall survival (OS)
Time frame: Up to approximately 60 months.
3-year overall survival (OS) rate
Time frame: Up to approximately 60 months.
2-year progression-free survival (PFS)
Time frame: Up to approximately 24 months.
Objective Response Rate (ORR)
Time frame: Up to approximately 36 months.
Duration of response (DoR)
Time frame: Up to approximately 60 months.
Local recurrence rate
Time frame: Up to approximately 36 months.
Distant metastasis rate
Time frame: Up to approximately 60 months.
The second disease progression assessed by the investigator
Time frame: Up to approximately 60 months.
Adverse events (AEs) including incidence and grade correlation with study drugs
Time frame: Up to approximately 60 months.
Rate of suspension and discontinuation due to an adverse event correlation with study drugs
Time frame: Up to approximately 60 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-1316 Injection, Cisplatin Injection and Carboplatin Injection in people with 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 6 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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoxu Zhang (+86-0518-82342973, xiaoxu.zhang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Up to approximately 36 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 15 Apr 2026.