Recurrent Cervical CancerPhase 3NCT07418749
A Study of SHR-A2102 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-based Chemotherapy and PD-(L)1 Inhibitor Treatment Failed Recurrent or Metastatic Cervical Cancer
A Phase 3 study testing SHR-A2102 for Injection, Pemetrexed Disodium for Injection and Gemcitabine Hydrochloride for Injection in people with Recurrent Cervical Cancer and Metastatic Cervical Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The main objective of this study is to evaluate the efficacy of SHR-A2102 versus investigator's choice of chemotherapy in patients with platinum-based chemotherapy and PD-(L)1 inhibitor treatment failed recurrent or metastatic cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Cervical Cancer, Metastatic Cervical Cancer
- What is being tested?
- SHR-A2102 for Injection, Pemetrexed Disodium for Injection and Gemcitabine Hydrochloride for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2026to 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participate in the study voluntarily, sign the informed consent form.
- Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma that is deemed unsuitable for radical surgery and/or radical radiotherapy or chemoradiotherapy.
- Provide primary or metastatic tumor samples.
- At least one measurable lesion (RECIST version 1.1).
- ECOG 0~ 1.
- With adequate organ functions.
- Expected overall survival is ≥12 weeks.
Who cannot join
- With known untreated or active central nervous system (CNS) tumor metastasis, or a history of or current leptomeningeal metastasis.
- With symptomatic, poorly controlled, or moderate-to-severe pleural effusion, pericardial effusion, or ascites.
- With a history of or concurrent other malignant tumor(s).
- Participants with gastrointestinal perforation or fistula, urogenital fistula, or those at risk of fistula within 3 months prior to randomization.
- With known or suspected interstitial lung disease.
- With intestinal obstruction or signs/symptoms suggestive of intestinal obstruction within 3 months prior to randomization.
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- With poorly controlled cardiac clinical symptoms or diseases.
- Experienced arterial/venous thromboembolic events within 3 months prior to randomization.
- With severe infections occurring within 1 month prior to randomization.
- With active hepatitis B (defined as positive hepatitis B surface antigen [HBsAg] test and hepatitis B virus [HBV] DNA ≥500 IU/mL at screening) or active hepatitis C (defined as positive hepatitis C virus antibody [HCV-Ab] test and detectable hepatitis C virus [HCV] RNA at screening).
- With active tuberculosis infection within 1 year prior to randomization, or a history of active tuberculosis infection more than 1 year ago without proper treatment.
- With a history of immunodeficiency, including a positive human immunodeficiency virus (HIV) test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- Have received systemic anti-tumor therapy within 28 days prior to randomization.
- With uncontrolled psychiatric disorders, or known history of alcoholism, drug abuse, or substance dependence, incarceration, or other conditions that may affect the completion of study procedures.
- Any other condition that, in the judgment of the investigator, may increase the risk associated with study participation, interfere with the interpretation of study results, or make the participant unsuitable for 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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Jihong Liu, +86-020-87341614, LIUJH@SYSUCC.ORG.CN
Jihong Liu
About this study
Official title: An Open-label, Randomized, Controlled, Multicenter, Phase III Study of SHR-A2102 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-based Chemotherapy and PD-(L)1 Inhibitor Treatment Failed Recurrent or Metastatic Cervical Cancer
The main objective of this study is to evaluate the efficacy of SHR-A2102 versus investigator's choice of chemotherapy in patients with platinum-based chemotherapy and PD-(L)1 inhibitor treatment failed recurrent or metastatic cervical cancer.
- Being tested
- SHR-A2102 for Injection, Pemetrexed Disodium for Injection, Gemcitabine Hydrochloride for Injection, Topotecan Hydrochloride for Injection, Paclitaxel for Injection (Albumin bound)
- 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.
SHR-A2102 for InjectionDrug
SHR-A2102 for injection.
Pemetrexed Disodium for InjectionDrug
Pemetrexed Disodium for injection.
Gemcitabine Hydrochloride for InjectionDrug
Gemcitabine Hydrochloride for injection.
Topotecan Hydrochloride for InjectionDrug
Topotecan Hydrochloride for injection.
Paclitaxel for Injection (Albumin bound)Drug
Paclitaxel for injection (Albumin bound).
| Study group | Role | What they receive |
|---|---|---|
| SHR-A2102 Group | Experimental | Participants receive SHR-A2102 for injection. Receives: Drug: SHR-A2102 for Injection |
| The investigator's choice of chemotherapy Group | Active comparator | Participants receive the investigator's choice of chemotherapy, with optional chemotherapeutic agents including: Pemetrexed Disodium for Injection, Gemcitabine Hydrochloride for Injection, Topotecan Hydrochloride for Injection, Paclitaxel for Injection (Albumin bound). Receives: Drug: Pemetrexed Disodium for Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Topotecan Hydrochloride for Injection; Drug: Paclitaxel for Injection (Albumin bound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 3 years.
Secondary outcomes (10)
Progression free survival (PFS)
Assessed by the investigator according to RECIST 1.1 criteria.
Measured: Up to 3 years.
Objective Response Rate (ORR)
Assessed by the investigator according to RECIST 1.1 criteria.
Measured: Up to 3 years.
Duration of response (DoR)
Assessed by the investigator according to RECIST 1.1 criteria.
Measured: Up to 3 years.
Disease control rate (DCR)
Assessed by the investigator according to RECIST 1.1 criteria.
Measured: Up to 3 years.
Adverse Events (AEs)
Including incidence and grade, judged according to NCI-CTCAE V5.0 standards.
Measured: Up to 3 years.
Serious Adverse Events (AEs)
Including incidence and grade, judged according to NCI-CTCAE V5.0 standards.
Measured: Up to 3 years.
Plasma concentrations of SHR-A2102
Pharmacokinetics (PK) traits of SHR-A2102.
Measured: Up to 3 years.
Plasma concentrations of SHR-A2102 metabolites
Pharmacokinetics (PK) traits of SHR-A2102.
Measured: Up to 3 years.
Incidence of Anti-Drug Antibody (ADA) of SHR-A2102
Measured: Up to 3 years.
Incidence of Neutralizing Antibodies (Nab) of SHR-A2102
Measured: Up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start30 Mar 2026
- Primary completionDec 2027 (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 Recurrent Cervical CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An open-label, randomized, controlled, multicenter, phase III Study.
- Masking
- None (open label)
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418749
- Sponsor's protocol ID
- SHR-A2102-310
- Status last verified
- Apr 2026
- First submitted
- 11 Feb 2026
- Last updated
- 6 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Controlled, Multicenter, Phase III Study of SHR-A2102 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-based Chemotherapy and PD-(L)1 Inhibitor Treatment Failed Recurrent or Metastatic Cervical Cancer
- ClinicalTrials.gov ID
- NCT07418749
- Acronym / sponsor ID
- SHR-A2102-310
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Feb 2026 (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 main objective of this study is to evaluate the efficacy of SHR-A2102 versus investigator's choice of chemotherapy in patients with platinum-based chemotherapy and PD-(L)1 inhibitor treatment failed recurrent or metastatic cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open-label, randomized, controlled, multicenter, phase III Study.
| Arm | Type | Receives |
|---|---|---|
| SHR-A2102 Group | Experimental | Drug: SHR-A2102 for InjectionParticipants receive SHR-A2102 for injection. |
| The investigator's choice of chemotherapy Group | Active comparator | Drug: Pemetrexed Disodium for Injection, Drug: Gemcitabine Hydrochloride for Injection, Drug: Topotecan Hydrochloride for Injection, Drug: Paclitaxel for Injection (Albumin bound)Participants receive the investigator's choice of chemotherapy, with optional chemotherapeutic agents including: Pemetrexed Disodium for Injection, Gemcitabine Hydrochloride for Injection, Topotecan Hydrochloride for Injection, Paclitaxel for Injection (Albumin bound). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participate in the study voluntarily, sign the informed consent form.
- Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma that is deemed unsuitable for radical surgery and/or radical radiotherapy or chemoradiotherapy.
- Provide primary or metastatic tumor samples.
- At least one measurable lesion (RECIST version 1.1).
- ECOG 0~ 1.
Key exclusion criteria (15 listed)
- With known untreated or active central nervous system (CNS) tumor metastasis, or a history of or current leptomeningeal metastasis.
- With symptomatic, poorly controlled, or moderate-to-severe pleural effusion, pericardial effusion, or ascites.
- With a history of or concurrent other malignant tumor(s).
- Participants with gastrointestinal perforation or fistula, urogenital fistula, or those at risk of fistula within 3 months prior to randomization.
- With known or suspected interstitial lung 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 |
|---|---|---|
| SHR-A2102 for InjectionSHR-A2102 for injection. | Drug | SHR-A2102 Group |
| Pemetrexed Disodium for InjectionPemetrexed Disodium for injection. | Drug | The investigator's choice of chemotherapy Group |
| Gemcitabine Hydrochloride for InjectionGemcitabine Hydrochloride for injection. | Drug | The investigator's choice of chemotherapy Group |
| Topotecan Hydrochloride for InjectionTopotecan Hydrochloride for injection. | Drug | The investigator's choice of chemotherapy Group |
| Paclitaxel for Injection (Albumin bound)Paclitaxel for injection (Albumin bound). | Drug | The investigator's choice of chemotherapy Group |
Primary outcome
Overall survival (OS)
Time frame: Up to 3 years.
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up.
10 secondary outcomes
Progression free survival (PFS)
Time frame: Up to 3 years.
Objective Response Rate (ORR)
Time frame: Up to 3 years.
Duration of response (DoR)
Time frame: Up to 3 years.
Disease control rate (DCR)
Time frame: Up to 3 years.
Adverse Events (AEs)
Time frame: Up to 3 years.
Serious Adverse Events (AEs)
Time frame: Up to 3 years.
Plasma concentrations of SHR-A2102
Time frame: Up to 3 years.
Plasma concentrations of SHR-A2102 metabolites
Time frame: Up to 3 years.
Incidence of Anti-Drug Antibody (ADA) of SHR-A2102
Time frame: Up to 3 years.
Incidence of Neutralizing Antibodies (Nab) of SHR-A2102
Time frame: Up to 3 years.
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 6 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-A2102 for Injection, Pemetrexed Disodium for Injection and Gemcitabine Hydrochloride for Injection in people with Recurrent Cervical Cancer and Metastatic Cervical Cancer, run by Suzhou Suncadia Biopharmaceuticals 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 7 inclusion and 15 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 6 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. 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 Zhifei Lin (+86-0518-82342973, zhifei.lin.zl3@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Up to 3 years.). 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 6 Apr 2026.