Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Uterine Cervical Neoplasms

Recurrence

Disease Attributes

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Pemetrexed

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Albumin-bound paclitaxel injection or Pemetrexed disodium for injection or Gemcitabine for injection

SHR-1210

SHR-1020

Investigators will declare one of the following regimens:Albumin-bound paclitaxel injection, Pemetrexed disodium for injection, Gemcitabine for injection

Physician's choice chemotherapy

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).

A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer

A Randomized,Open-label, Multi-Center, Phase II Clinical Trial to Assess the Efficacy and Safety of SHR-1210± SHR-1020 Versus Physician's Choice Chemotherapy in the Treatment of Recurrent or Metastatic Cervical Cancer Patients

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.

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.

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

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.

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.

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.

Defined as the time from randomization to the end of treatment or death from any cause, whichever came first.

To calculate the proportion of dose interruption, dose reduction or dose termination because of drug-related toxicity

Defined as ratio of ADAs of SHR-1210 during the treatment compared to baseline.

Defined as peak serum concentration of SHR-1210 during the treatment compared to baseline

Defined as peak plasma concentration of famitinib during the treatment compared to baseline

Defined as area under the serum concentration versus time curve of SHR-1210 during the treatment compared to baseline

Defined as area under the plasma concentration versus time curve of famitinib during the treatment compared to baseline

Jiangsu HengRui Medicine Co., Ltd.

Antibodies

Antibodies, Bispecific

Immunoglobulins

recurrent or metastatic cervical cancer in the first, second or third lines Systematic treatment

Cadonilimab

Ding Ma

Gang Chen

This real-world study included all patients with recurrent or metastatic cervical cancer who used Cadonilimab in clinical practice, regardless of treatment lines and combination with different treatments. Through follow-up observations, the aim of this study is to analyze the efficacy of Cadonilimab for recurrent or metastatic cervical cancer in the real world, and to explore the differences in the efficacy of Cadonilimab in different stages of treatment, as well as the efficacy of different treatment combinations, so as to provide clinical evidence for the use of Cadonilimab for recurrent or metastatic cervical cancer.

A Prospective Real-world Study of Cadonilimab in Patients With Recurrent or Metastatic Cervical Cancer

Efficacy and Safety of Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) in the Treatment of Recurrent or Metastatic Cervical Cancer: a Multicenter, Prospective, Real-world Study

ORR is proportion of subjects with complete response(CR) or partial response(PR), based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1

Disease control rate (DCR) is defined as the proportion of subjects achieving a best of response(BOR) of confirmed CR and PR and stable disease(SD) per RECIST v1.1.

Progression-free survival (PFS) is defined as the time from the first dose of investigational products until documentation of PD (as per RECIST v1.1) or death due to any cause, whichever occurs first.

Overall survival (OS) is defined as the time from the first dose of investigational products until death due to any cause.

Incidence and severity of AEs is aim to evaluate the safety of Cadonilimab in combination with other treatments.

Gang Chen (101199)

Professor

Analgesics

Interleukin-2

Analgesics, Non-Narcotic

Participants in the 2 dose groups will receive HPV-T injections of 5×10\^9 and 1.5×10\^10 cells intravenously each time.

Participant will receive HPV-T iv on day 0. One time of cell infusion constitute a cycle, each participant receives up to four cycles of treatment

HPV-T

500,000IU/m\^2 SC, after each cell infusion, IL-2 will start within 24 hours and every 8-12 hours for up to 6 doses.

Guiling Li, Doctor

Guiling Li, doctor

The purpose of this protocol is to evaluate the feasibility and safety of HPV-T in HPV 16 positive recurrent or metastatic solid tumor patients.

In this study, HPV-T cells will be cultured from mononuclear cells collected from participant's peripheral blood in the laboratory and they will be given back to the participant intravenously. The use of HPV-T cells involves a combination of IL-2, which is a drug used to help the body's response to treatment on the immune system. A medium dose regimen of IL-2 will be given after the participant receives the infusion of the T-cells.

Each HPV-T cell reinfusion is a treatment cycle, and each participant will receive a maximum of four cycles of HPV-T treatment. Whether the participant receives the next cycle of treatment depends on the efficacy of the previous HPV-T treatment, which is assessed by imaging.

HPV-T in HPV-16 Positive Recurrent or Metastatic Solid Tumors

A Phase 1 Study to Assess the Feasibility and Safety of Tumor HPV-E6/E7-Targeting T Cell Suspension for Intravenous Infusion (HPV-T) in Patients With HPV-16 Positive Recurrent or Metastatic Solid Tumor

Toxicity will be assessed within 4 weeks of the HPV-T transfer.

Participants displaying objective response associated with the treatment regimen per Response Evaluation Criteria in Solid Tumors (RECIST v.1.1). The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Disease control rate (DCR), Duration of Response (DOR), Overall Survival(OS) and Progression-free survival (PFS) will be also evaluated.

Wuhan Union Hospital, China

BGI, China

Carboplatin

Bevacizumab

Cisplatin

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

AK104 intravenously(IV) every 3 weeks (Q3W)

Paclitaxel 175mg/m2 IV every 3 weeks (Q3W)

Cisplatin 50mg/m2 or Carboplatin AUC5 IV every 3 weeks (Q3W)

AK104 every 3 weeks (Q3W)

Bevacizumab 15mg/kg IV every 3 weeks (Q3W)

Paclitaxel 175mg/m2 IV every 3 weeks (Q3W)

Cisplatin 50mg/m2 or Carboplatin AUC5 IV every 3 weeks (Q3W)

Subjects will receive AK104 intravenously.

AK104

Subjects will receive Bevacizumab intravenously.

Subjects will receive Paclitaxel intravenously.

Subjects will receive Cisplatin or Carboplatin intravenously.

Cisplatin or Carboplatin

Jing Wang, MD

Hanmei Lou

This is a multicenter, open-label, phase II clinical study conducted in China. All subjects will receive AK104 in combination with standard treatment regimens or AK104 alone. The primary end point is safety. The secondary end point is efficacy.

A Study of AK104（ an Anti-PD-1 and Anti-CTLA-4 Bispecific Antibody) in Recurrent or Metastatic Cervical Cancer

A Multicenter, Open-label, Phase II Study of AK104（an Anti-PD-1 and Anti-CTLA-4 Bispecific Antibody) in the Treatment of Recurrent or Metastatic Cervical Cancer

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment

The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.

Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.

The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.

Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.

Overall survival is defined as the time from the start of treatment with AK104 until death due to any cause.

The endpoints for assessment of PK of AK104 include serum concentrations of AK105 at different timepoints after AK104 administration.

The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).

PD-L1 expression will be determined by IHC in the central laboratory.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer	NCT04680988	Recurrent or Me...	SHR-1210 SHR-1020 Physician's cho...	18 Years - 75 Years	Jiangsu HengRui Medicine Co., Ltd.
A Prospective Real-world Study of Cadonilimab in Patients With Recurrent or Metastatic Cervical Cancer	NCT06155422	Recurrent or Me...	Cadonilimab	18 Years - 90 Years	Tongji Hospital
HPV-T in HPV-16 Positive Recurrent or Metastatic Solid Tumors	NCT05895370	Solid Tumor	HPV-T Interleukin-2	18 Years - 75 Years	BGI, China
A Study of AK104（ an Anti-PD-1 and Anti-CTLA-4 Bispecific Antibody) in Recurrent or Metastatic Cervical Cancer	NCT04868708	Recurrent or Me...	AK104 Bevacizumab Paclitaxel Cisplatin or Ca...	18 Years - 75 Years	Akeso
HPV-T in HPV-16 Positive Recurrent or Metastatic Solid Tumors	NCT05895370	Solid Tumor	HPV-T Interleukin-2	18 Years - 75 Years	BGI, China

Spots Global Cancer Trial Database for recurrent or metastatic cervical cancer