NCT04731038

Brief Summary

This is a single center phase 1 trail to observe safety and efficacy of Paclitaxel plus Cisplatin\\Carboplatin, PD-L1 antibody Toripalimab and Anlotinib as first-line regimen to treat the patient with metastatic 、persistent or recurrent disease after radical surgery、radical platinum-based concurrent chemoradiotherapy or both (Stage IA-IVA).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 27, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

January 27, 2021

Last Update Submit

September 16, 2021

Conditions

Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (1)

  • Safety: adverse events as assessed by CTCAE v5.0

    36 months

Secondary Outcomes (5)

  • Progression free survival

    36 months

  • Overall survival

    36 months

  • Objective response rate

    36 months

  • Disease control rate

    36 months

  • Duration of response

    36 months

Study Arms (1)

Experimental

EXPERIMENTAL

Anlotinib 12mg qd. po. d1-d14 q3w Toripalimab 240mg ivgtt. d1 q3w Paclitaxel 135mg/m2 ivgtt. d1 q3w Cisplatin 50mg/m2 ivgtt. d1 q3w Carboplatin AUC=5 ivgtt. d1 q3w

Drug: Anlotinib, Toripalimab, Paclitaxel, Cisplatin/ Carboplatin

Interventions

Anlotinib, Toripalimab, Paclitaxel, Cisplatin/ CarboplatinDRUG

This is a single-arm study with all patients receiving these four drugs.

Experimental

Eligibility Criteria

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

You may qualify if:

  • female patients aged≥18 years.
  • Histologically confirmed cervical squamous cell carcinoma or adenocarcinoma, without uncontrolled pleural effusion or ascites.
  • Patients with advanced or metastatic disease who have disease progression after radical surgery、radical platinum-based concurrent chemoradiotherapy or both （Stage IA-IVA）, with measurable lesions.
  • ECOG performance status 0 or 2, expected lifetime≥3 months.
  • Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥100x109/L, Hemoglobin (Hb) ≥100g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
  • HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA\<500IU/ml (or 2500 copies/ml).
  • Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment.
  • Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form.

You may not qualify if:

  • Pregnancy or children bearing potential.
  • brain or meningeal metastasis.
  • With second primary malignant diseases.
  • With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (\>10mg/d prednisone).
  • With uncontrollable complications
  • Inadequate organ function
  • Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction).
  • known hypersensitivity reaction to any of the study drugs or components.
  • Other unsuitable conditions determined by investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Ruijin Hospital

Shanghai, 200025, China

RECRUITING

MeSH Terms

Interventions

anlotinibtoripalimabPaclitaxelCisplatinCarboplatin

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCoordination Complexes

Study Officials

  • Jun Zhang, MD & Ph. D

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenqi Xi

CONTACT

+86-13601782226xwq11061@rjh.com.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Department of Oncology

Study Record Dates

First Submitted

January 27, 2021

First Posted

January 29, 2021

Study Start

August 1, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2024

Last Updated

September 17, 2021

Record last verified: 2021-09

Locations

CN(1)