NCT07168200

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for phase_3

Timeline
31mo left

Started Oct 2025

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Oct 2025Dec 2028

First Submitted

Initial submission to the registry

September 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 17, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

September 4, 2025

Last Update Submit

April 12, 2026

Conditions

Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

    Up to approximately 36 months.

Secondary Outcomes (10)

  • Overall survival (OS)

    Up to approximately 60 months.

  • 3-year overall survival (OS) rate

    Up to approximately 60 months.

  • 2-year progression-free survival (PFS)

    Up to approximately 24 months.

  • Objective Response Rate (ORR)

    Up to approximately 36 months.

  • Duration of response (DoR)

    Up to approximately 60 months.

  • +5 more secondary outcomes

Study Arms (2)

SHR-1316 Group

EXPERIMENTAL
Drug: SHR-1316 InjectionDrug: Cisplatin InjectionDrug: Carboplatin InjectionDrug: Paclitaxel Injection

SHR-1316 Placebo Group

PLACEBO COMPARATOR
Drug: Cisplatin InjectionDrug: Carboplatin InjectionDrug: Paclitaxel InjectionDrug: SHR-1316 Placebo Injection

Interventions

SHR-1316 InjectionDRUG

SHR-1316 injection.

SHR-1316 Group
Cisplatin InjectionDRUG

Cisplatin injection.

SHR-1316 GroupSHR-1316 Placebo Group
Carboplatin InjectionDRUG

Carboplatin injection.

SHR-1316 GroupSHR-1316 Placebo Group
Paclitaxel InjectionDRUG

Paclitaxel injection.

SHR-1316 GroupSHR-1316 Placebo Group
SHR-1316 Placebo InjectionDRUG

SHR-1316 placebo injection.

SHR-1316 Placebo Group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

CisplatinCarboplatinPaclitaxel

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCoordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Central Study Contacts

Xiaoxu Zhang

CONTACT

+86-0518-82342973xiaoxu.zhang@hengrui.com

Zhaoyu Zhong

CONTACT

+86-0518-82342973zhaoyu.zhong.zz8@hengrui.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2025

First Posted

September 11, 2025

Study Start

October 17, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

CN(1)