Camrelizumab Combined With Famitinib Malate and Chemotherapy for Treatment of Recurrent/ Metastatic Cervical Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorHunan Cancer Hospital

About this trial

This study is an open-label, multi-center Phase II clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate and platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female aged 18-75 years.

Histopathologically confirmed recurrent/metastatic cervical squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma that cannot be radically treated by surgery, radiotherapy or chemoradiotherapy.

No prior systemic anti-cancer therapy for recurrent/metastatic disease.

According to RECIST v1.1 criteria, the patient must have at least one measurable lesion.

Disqualifiers

Has any malignancy <5 years prior to study entry.

Known to have brain or meningeal metastasis.

Known to have autoimmune disease.

Received live vaccinations 4 weeks before randomization or during the study period.

Trial design

Design model

Single group

Treatments tested in this trial

  • Camrelizumab

    Drug

    Intravenous (IV) on Day 1 of each cycle

  • Famitinib Malate

    Drug

    Famitinib po qd

  • Chemotherapy

    Drug

    Paclitaxel + cisplatin or carboplatin

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: Camrelizumab combined with famitinib malate and chemotherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Objective Response Rate defined as the percentage of participants who have a complete response or a partial response (PR) per RECIST 1.1.

Time frame
up to 2 years

Secondary outcomes

1

Disease control rate (DCR)

DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.

Time frame
up to 2 years
2

Duration of response (DOR)

Duration of Response per RECIST 1.1.

Time frame
Up to 2 years
3

Time to response (TTR)

TTR is defined as the time from the date of first dose until the date of first documented response per RECIST 1.1.

Time frame
up to 2 years
4

Progression-free survival (PFS)

PFS is defied as time from the date of first dose to first documented of disease progression (RECIST1.1) or date of death.

Time frame
Up to 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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