Pd-1 Antibody Combined CCRT for Local Advanced Cervical Cancer.

NCT04368273 | Unknown Phase 1 DMC

• 1 other identifier: M2019482
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of anti-PD-1 (toripalimab) combined with cisplatin concurrent IMRT for locally advanced cervical cancer.

Conditions

Cervical Cancer

Keywords

PD-1; Radiotherapy; concurrent chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of acute adverse events

  safety evaluation

  up to 3 months complete treatment

Secondary Outcomes (2)

• Objective response rate

  3 months later after treatment

• Progression-free survival

  up to 2 years

Study Arms (1)

treatment

EXPERIMENTAL

PD-1 antibody combined CCRT for patients with local advanced cervical cancer.

Drug: PD-1 antibody

Interventions

PD-1 antibody DRUG

a new treatment drug combined radical radiotherapy concurrent chemotharpy

Also known as: Toripalimab

treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HPV positive in patients with cervical squamous cell carcinoma confirmed by histopathology
• Patients with local advanced (2018FIGO staged IB3, IIA -IVA) cervical cancer and had not received any treatment before
• There are measurable lesions according to the efficacy evaluation criteria for solid tumors (RECIST) version 1.1
• ECOG score 0-2
• Expected survival ≥3 months
• LVEF≥55%
• Bone marrow function: neutrophils ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥90g/L
• Liver and kidney functions: serum creatinine ≤1.5 times the upper limit of normal value;AST and ALT ≤2.5 times normal upper limit or ≤5 times normal upper limit in the presence of liver metastasis;Total bilirubin ≤1.5 times the upper limit of normal value, or ≤2.5 times the upper limit of normal value in patients with Gilbert's syndrome
• Thyroid function: normal range
• Non-lactating patients
• Sign the informed consent

You may not qualify if:

• Patients with previous PD-1 or PD-L1 treatment
• Patients with previous abdominal or pelvic radiotherapy
• Other malignant tumors other than cervical cancer appeared in the past 5 years
• Immunosuppressive drugs were used within 4 weeks prior to the first study treatment, excluding nasal spray, inhaled or other local glucocorticoids or systemic glucocorticoids in physiological doses (i.e., no more than 10 mg/ day prednisone or equivalent doses of other glucocorticoids)
• Active, known, or suspected autoimmune disease (congenital or acquired)
• ), such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroiditis, etc. (vitiligo or childhood asthma has been completely relieved, adults without any intervention can be included;Patients with type 1 diabetes with good insulin control can also be enrolled, as can hypothyroidism caused by autoimmune thyroiditis that requires hormone replacement therapy.)
• Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
• Known allergy to any component of the drug
• Serious medical diseases that are not under control, such as the combination of serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension,uncontrolled infection, active peptic ulcer
• Received other experimental drugs or participated in other drugs within 30 days of initial administration clinical research on the purpose of anticancer therapy
• Severe infection occurred within 4 weeks prior to study treatment, including, but not limited to, hospitalization hospital treatment of infection complications, bacteremia or severe pneumonia
• Human immunodeficiency virus (HIV) positive
• Hepatitis B surface antigen (HBsAg) positive, and the peripheral blood hepatitis B virus deoxygenation the titer of ribonucleic acid (HBV-DNA) was detected in subjects ≥1×10\<3\> IU/mL
• Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) Antibody positive and HCV RNA positive

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University 3rd Hospital

Beijing, Beijng, 100191, China

Location

Related Publications (1)

• Jiang P, Wei S, Li C, Qu A, Chen H, Zhang H, Guo H, Wang J. Safety and efficacy of toripalimab plus concurrent chemoradiotherapy for locally advanced cervical cancer: a single-arm, phase Ib trial. BMC Cancer. 2025 Oct 14;25(1):1566. doi: 10.1186/s12885-025-15059-y.

  PMID: 41087995 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

spartalizumab; toripalimab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Junjie Wang, MD

  Peking University 3rd Hospital radiation oncology department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Jiang, MD

CONTACT

010-82266699; drjiangping@qq.com

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: Department director

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: April 29, 2020
• Study Start: May 8, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: April 29, 2020

Record last verified: 2020-04

Locations

CN (1)