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Cervical CancerPhase 3NCT05179239

A Study of SHR-1701 Plus Platinum-containing Chemotherapy With or Without BP102 (Bevacizumab) as First-line Treatment in Cervical Cancer

A Phase 3 study testing SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102 and SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102 in people with Cervical Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102 and SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
1 siteChina
Study dates
26 Feb 2022to 12 Aug 2024
Phase
Phase 3
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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-70 years, female.
  • With Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1.
  • With a life expectancy of ≥ 12 weeks.
  • Acute toxicities from prior anti-tumor treatments must have resolved to Grade 0-1 (per NCI CTCAE 5.0).
  • With at least one measurable lesion as per RECIST v1.1.
  • With histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix.
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  • Persistent, recurrent, or metastatic cervical cancer.
  • Patients to be enrolled in Stage II are required to provide a minimum of 10 slides of fresh (preferred).
  • Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to starting study treatment.
  • Patients must agree and have signed the informed consent form.

Who cannot join

  • With known contraindications to paclitaxel, cisplatin, or carboplatin.
  • With known allergies to any of the study drugs or their excipients; severe allergic reactions to other monoclonal antibodies.
  • With inadequately treated CNS metastasis.
  • With uncontrolled hypertension.
  • With uncontrolled cardiac diseases or symptoms.
  • With major vascular disease.
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  • With arterial/venous thrombotic events within 6 months prior to randomization.
  • Have received full-dose anticoagulant or hemolytic therapy within 10 days prior to randomization.
  • With clinically significant hemorrhage or definitive bleeding diathesis within 3 months prior to randomization.
  • With severe, unhealed, or open wounds as well as active ulcers or untreated fractures.
  • With any active autoimmune disease or a history of autoimmune disease that is expected to recur.
  • Had other active malignant tumors within 5 years prior to study enrolment.
  • With congenital or acquired immunodeficiency (such as HIV-infected patients).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: A Randomized，Double-blind，Controlled，Multi-center Phase III Clinical Study Evaluating SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer

The study is being conducted to evaluate the efficacy, and safety of SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab) as First-Line Treatment in Patients With Persistent, Recurrent, or Metastatic Cervical Cancer.

Conditions
Cervical Cancer
Being tested
SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102, SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102, Placebo + paclitaxel + cisplatin/carboplatin ± BP102
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-1701 + paclitaxel + cisplatin/carboplatin + BP102Drug

    SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102

  • SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102Drug

    SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102

  • Placebo + paclitaxel + cisplatin/carboplatin ± BP102Drug

    Placebo + paclitaxel + cisplatin/carboplatin ± BP102

Study groups in NCT05179239
Study groupRoleWhat they receive
SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102ExperimentalNot described
Receives: Drug: SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102
SHR-1701 + paclitaxel + cisplatin/carboplatin ± BP102ExperimentalNot described
Receives: Drug: SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102
Placebo + paclitaxel + cisplatin/carboplatin ± BP102Placebo comparatorNot described
Receives: Drug: Placebo + paclitaxel + cisplatin/carboplatin ± BP102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of Participants Who Experience an Adverse Event (AE) as per NCI-CTC AE 5.0（Stage I）

    Measured: Up to approximately 21 days

  2. Incidence and severity of Participants Who Experience a Serious AE (SAE) as per NCI-CTC AE 5.0（Stage I）

    Measured: Up to approximately 21 days

  3. Incidence and severity of Participants Who Experience an Immune-related AE (irAE) as per NCI-CTC AE 5.0（Stage I）

    Measured: Up to approximately 21 days

  4. BIRC-assessed progression-free survival (PFS) as per RECIST v1.1（Stage II）

    Measured: Up to approximately 10 months

  5. OS is defined as the time from randomization to death due to any cause. （Stage II）

    Measured: Up to approximately 26 months

Secondary outcomes (14)

  1. Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator （Stage I）

    Measured: Up to approximately 26 months

  2. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator （Stage I）

    Measured: Up to approximately 26 months

  3. Disease Control Rate (DCR)up to approximately 26 months（Stage I）

    Measured: up to approximately 26 months

  4. Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator （Stage I）

    Measured: Up to approximately 26 months

  5. Time to Progress(TTP) up to approximately 26 months（Stage I）

    The time from the date of the first medication to the date of the first recording of tumor progression (as measured according to THE RECIST v1.1 criteria, regardless of whether treatment is continued or not).

    Measured: up to approximately 26 months

  6. Overall survival (OS) up to approximately 26 months（Stage I）

    Measured: up to approximately 26 months

  7. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by BIRC- and investigator（Stage II）

    Measured: Up to approximately 26 months

  8. Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BIRC- and investigator（Stage II）

    Measured: Up to approximately 26 months

  9. Disease Control Rate (DCR)Per RECIST 1.1 as Assessed by BIRC- and investigator（Stage II）

    Measured: Up to approximately 26 months

  10. Duration of Response (DOR) Per RECIST 1.1 as Assessed by BIRC- and investigator （Stage II）

    Measured: Up to approximately 26 months

  11. Time to Progress(TTP) up to approximately 26 months （Stage II）

    The time from the date of randomization to the date of the first recording of tumor progression (as measured according to THE RECIST v1.1 criteria, regardless of whether treatment is continued or not).

    Measured: up to approximately 26 months

  12. Incidence and severity of Participants Who Experience an Adverse Event (AE) as per NCI-CTC AE 5.0 （Stage II）

    Measured: Up to approximately 26 months

  13. Incidence and severity of Participants Who Experience a Serious AE (SAE) as per NCI-CTC AE 5.0（Stage II）

    Measured: Up to approximately 26 months

  14. Incidence and severity of Participants Who Experience an Immune-related AE (irAE) as per NCI-CTC AE 5.0（Stage II）

    Measured: Up to approximately 26 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2022
  2. Study start26 Feb 2022
  3. Primary completion12 Aug 2024
  4. Study completion12 Aug 2024

Why it stopped: Sponsor develops strategy adjustment

Resources

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
SHR-1701 or Placebo Plus Chemotherapy With or Without BP102 (Bevacizumab)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05179239
Sponsor's protocol ID
SHR-1701-III-309
Status last verified
Apr 2025
First submitted
14 Oct 2021
Last updated
15 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Feng J, Tang D, Wang J, Zhou Q, Peng J, Lou H, Sun Y, Cai Y, Chen H, Yang J, Liu P, Wang L, Zou J. SHR-1701, a Bifunctional Fusion Protein Targeting PD-L1 and TGFbeta, for Recurrent or Metastatic Cervical Cancer: A Clinical Expansion Cohort of a Phase I Study. Clin Cancer Res. 2022 Dec 15;28(24):5297-5305. doi: 10.1158/1078-0432.CCR-22-0346.

    PubMed 35653122

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SHR-1701 + paclitaxel + cisplatin/carboplatin + BP102 and SHR-1701 + paclitaxel + cisplatin/carboplatin± BP102 in people with 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 10 inclusion and 13 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: stopped early, as of the sponsor's last update on 15 Apr 2025. 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?

The study was stopped early (reason given: Sponsor develops strategy adjustment). 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?

Incidence and severity of Participants Who Experience an Adverse Event (AE) as per NCI-CTC AE 5.0（Stage I） (time frame: Up to approximately 21 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05179239, which also lists 1 linked publication.

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 2025.

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