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NCT Number: NCT07168200

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

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).

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Xiaohua Wu

CONTACT

[email protected]

+86-021-64175590

Xiaohua Wu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SHR-1316 Injection

Drug

SHR-1316 injection.

Cisplatin injection

Drug

Cisplatin injection.

Carboplatin injection

Drug

Carboplatin injection.

Paclitaxel Injection

Drug

Paclitaxel injection.

SHR-1316 Placebo Injection

Drug

SHR-1316 placebo injection.

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: Up to approximately 36 months.

Secondary outcomes

  1. Overall survival (OS)

    Time frame: Up to approximately 60 months.

    OS is the time interval from the start of treatment to death due to any reason or lost of follow-up.

  2. 3-year overall survival (OS) rate

    Time frame: Up to approximately 60 months.

    OS rate within 3 years.

  3. 2-year progression-free survival (PFS)

    Time frame: Up to approximately 24 months.

    PFS within 2 years.

  4. Objective Response Rate (ORR)

    Time frame: Up to approximately 36 months.

  5. Duration of response (DoR)

    Time frame: Up to approximately 60 months.

  6. Local recurrence rate

    Time frame: Up to approximately 36 months.

  7. Distant metastasis rate

    Time frame: Up to approximately 60 months.

  8. The second disease progression assessed by the investigator

    Time frame: Up to approximately 60 months.

  9. Adverse events (AEs) including incidence and grade correlation with study drugs

    Time frame: Up to approximately 60 months.

  10. Rate of suspension and discontinuation due to an adverse event correlation with study drugs

    Time frame: Up to approximately 60 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoxu Zhang

CONTACT

[email protected]

+86-0518-82342973

Zhaoyu Zhong

CONTACT

[email protected]

+86-0518-82342973

Sponsors and collaborators

Lead sponsor

Shanghai Shengdi Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 11, 2025
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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