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This is a randomized, open-label, 3-arm Phase 2 study to evaluate the efficacy and safety of SHR-1210 alone or with SHR-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical cancer patients. All enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity，any criterion for stopping the study drug or SHR-1210 treatment for up to 2 years.
This is a randomized, open-label, 3-arm Phase 2 study to evaluate the efficacy and safety of SHR-1210 alone or with SHR-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical cancer patients. All enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity，any criterion for stopping the study drug or SHR-1210 treatment for up to 2 years.The primary study hypotheses are that the combination of SHR-1210 plus SHR-1020 is superior to SHR-1210 or physician's choice chemotherapy with respect to: 1) Progression free survival(PFS) in recurrent or metastatic cervical cancer patients(SHR-1210+SHR-1020 versus SHR-1210；2) Overall survival(OS) in recurrent or metastatic cervical cancer patients(SHR-1210+SHR-1020 versus Physician's choice chemotherapy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doublet Arm | Experimental | SHR-1210+SHR-1020 |
|
| Single Arm | Experimental | SHR-1210 |
|
| Physician's choice chemotherapy | Active Comparator | Albumin-bound paclitaxel injection or Pemetrexed disodium for injection or Gemcitabine for injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 | Drug | SHR-1210 intravenously every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) assessed by Blinded Independent Central Review in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) | Defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) | PFS is defined as from the time of randomization until the date of first documented progression or date of death from any cause, whichever came first. | Up to approximately 2 years |
| Overall survival (OS) in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40561369 | Derived | Xia L, Zhang K, Tang Y, Zhang G, Wang D, Lou H, Liu N, Zhang H, Chen H, Wang K, Wei S, Wang L, Gao K, Li G, Zhang H, Hu Y, Zhao W, Zhang Y, Zhu H, Lin A, Miao J, Yu G, Hua K, Tang L, Liu Z, Zhang B, Li H, Zheng M, Wang X, Li F, Yang X, Zhou H, Xia B, Zhou X, Wang Y, Wang Q, Wu X. Camrelizumab Plus Famitinib versus Camrelizumab Alone and Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Cancer: A Randomized, Phase II Study. J Clin Oncol. 2025 Aug 20;43(24):2720-2733. doi: 10.1200/JCO-24-02495. Epub 2025 Jun 25. |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014594 | Uterine Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C584390 | famitinib |
| D000068196 | Albumin-Bound Paclitaxel |
| D000068437 | Pemetrexed |
| D007267 | Injections |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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| SHR-1020 | Drug | SHR-1020 Orally once daily |
|
|
| Physician's choice chemotherapy | Drug | Investigators will declare one of the following regimens:Albumin-bound paclitaxel injection, Pemetrexed disodium for injection, Gemcitabine for injection |
|
|
OS is the time interval from randomization to death due to any reason or lost of follow-up. |
| Up to approximately 2 years |
| Objective Response Rate (ORR) assessed by investigator in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) | Defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria. | Up to approximately 2 years |
| Disease control rate (DCR)，recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria | Defined as the number of subjects with a best overall response (BOR) of CR (Disappearance of all target lesions), PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) or SD (Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.) divided by the number of measurable subjects with target lesion at baseline according to RECIST 1.1 criteria. | Up to approximately 2 years |
| Duration of response (DoR), in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria. | For participants who demonstrate CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death from any cause, whichever came first. The DOR per RECIST 1.1 as assessed by Investigator will be presented. | Up to approximately 2 years |
| Time to response (TTR), in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria. | Defined as the time from randomization to the first objective tumor response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters)) observed for patients who achieved a CR or PR. | Up to approximately 2 years |
| Time to treatment failure (TTF)，in recurrent or metastatic cervical cancer patients(SHR-1210+Famitinib versus SHR-1210) according to RECIST 1.1 criteria. | Defined as the time from randomization to the end of treatment or death from any cause, whichever came first. | Up to approximately 2 years |
| Adverse Events (AEs) | from the first drug administration to within 90 days for the last treatment dose |
| Tolerance | To calculate the proportion of dose interruption, dose reduction or dose termination because of drug-related toxicity | from the first drug administration to within 90 days for the last treatment dose |
| Characteristic of Anti drug antibody | Defined as ratio of ADAs of SHR-1210 during the treatment compared to baseline. | from the first drug administration to within 90 days for the last treatment dose |
| Peak Serum Concentration of SHR-1210 | Defined as peak serum concentration of SHR-1210 during the treatment compared to baseline | from the first drug administration to within 90 days for the last treatment dose |
| Peak Plasma Concentration of famitinib | Defined as peak plasma concentration of famitinib during the treatment compared to baseline | from the first drug administration to within 90 days for the last treatment dose |
| Area under the Serum Concentration versus Time Curve of SHR-1210 | Defined as area under the serum concentration versus time curve of SHR-1210 during the treatment compared to baseline | from the first drug administration to within 90 days for the last treatment dose |
| Area under the Plasma Concentration versus Time Curve of famitinib | Defined as area under the plasma concentration versus time curve of famitinib during the treatment compared to baseline | from the first drug administration to within 90 days for the last treatment dose |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |