A Phase II Clinical Study to Assess the Efficacy and Safe... | NCT04590599

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
IBI310+Sintilimab	Experimental	IBI310+Sintilimab	Drug: IBI310 Drug: Sintilimab
Placebo+Sintilimab	Active Comparator	Placebo+Sintilimab	Drug: Placebo Drug: Sintilimab

Name	Type	Description	Arm Group Labels	Other Names
IBI310	Drug	IBI310 3 mg/kg,Q3W, for a total of 4 cycles	IBI310+Sintilimab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate (ORR)	Objective response rate (ORR) assessed by the Independent Radiological Review Committee (IRRC) according to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1	Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.
Objective response rate (ORR)	ORR assessed by the investigator according to the RECIST V1.1	Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.

Secondary Outcomes

Measure	Description	Time Frame
Disease Control Rate（DCR）	DCR assessed by the investigator and IRRC according to the RECIST V1.1	Assessed week 6,week 12,week 18 ,and every 9 weeks (or every 12 weeks after 54 weeks of treatment) for duration of study participation which is estimated to be 24 months.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol.
Aged ≥18 years and ≤75 years.
Diagnosed with cervical cancer by histology/cytology.
Patients with relapsed or metastatic cervical cancer who have had progressed or relapsed after receiving at least first-line of platinum-based chemotherapy (if a patient has progressed or relapsed during or within 6 months after receiving platinum-based neoadjuvant or adjuvant chemotherapy, she will be deemed to have received first-line treatment).
The subject's previous systemic treatment must have ended ≥4 weeks before the first study administration, and the treatment-related AEs have recovered to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 grade ≤1 (except for alopecia and fatigue).

Exclusion Criteria:

Diagnosis of other malignant tumors within 5 years before the first administration, excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, radically resected carcinoma in situ and/or thyroid papillary carcinoma.
Pleural effusion, ascites, and pericardial effusion with clinical symptoms or requiring drainage (patients with effusion that does not require drainage or patients with no significant increase in the effusion within 3 days after stopping drainage can be selected).
Patients who are planning to undergo or have previously received organ or bone marrow transplantation.
Patients with acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA> 200 IU/ml or 103 copies/ml; hepatitis C virus (HCV) antibody positive and HCV-RNA level higher than the lower limit of detection. Patients with acute or chronic active hepatitis B or C infection who have received nucleotide antiviral therapy and are below the above standards can be selected.
Meningeal metastases or symptomatic central nervous system (CNS) metastases. Patients with asymptomatic brain metastases who do not need treatment with glucocorticoids, anticonvulsants or mannitol after radiotherapy can be enrolled.

Facility	Status	City	State	ZIP	Country	Contacts
Innovent Biologics, Inc.		Suzhou	Jiangsu	215123	China
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital）

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39827881	Derived	Li H, Xu Y, Jiao X, Xu Q, Peng Z, Tang Y, Zhang J, Huang B, Shen Y, Chang B, Xia B, Duan W, Wang D, Zhu L, An R, Zhang G, Tang Y, Huang J, Qiu H, Wang L, Huang Y, Li G, Qian J, Sun L, Zheng H, Lou G, Zhang Y, Chen Y, Lu L, Cheng Y, Liu J, Zhao W, Ji J, He A, Wang K, Yu G, Zhu H, Ma C, Yuan J, Wang X, Zhang H, Ma X, Cai C, Yin K, Xie H, Wang Y, Wang S, Li L, Zhou H, Wang J, Zhu J, Ma D, Gao Q. IBI310 plus sintilimab vs. placebo plus sintilimab in recurrent/metastatic cervical cancer: A double-blind, randomized controlled trial. Med. 2025 May 9;6(5):100573. doi: 10.1016/j.medj.2024.100573. Epub 2025 Jan 18.