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

NCT ID: NCT04368273

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-08
• Study Completion Date: 2022-12-31

Brief Summary

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

Detailed Description

The dose of toripalimab injection (pd-1 antibody) was 240mg/d, d1, i.v. every 14d, totally 4 cycles (56 days)

Concurrent chemoradiotherapy:

Cisplatin 40 mg/m2 i.v., d1, administered once a week; Radiotherapy: pelvic intensity modulated radiotherapy, prescription dose DT: 50.4gy /2Gy/28f;After intraluminal irradiation DT: 30-36 Gy/6Gy/5-6f 2f/w, complete the radiotherapy within 56 days.

Complete at least 4 cycles of concurrent chemoradiotherapy.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment

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

Group Type: EXPERIMENTAL

PD-1 antibody

Intervention Type: DRUG

a new treatment drug combined radical radiotherapy concurrent chemotharpy

Interventions

PD-1 antibody

a new treatment drug combined radical radiotherapy concurrent chemotharpy

Intervention Type: DRUG

Other Intervention Names

Toripalimab

Eligibility Criteria

Inclusion Criteria

1. HPV positive in patients with cervical squamous cell carcinoma confirmed by histopathology

2. Patients with local advanced (2018FIGO staged IB3, IIA -IVA) cervical cancer and had not received any treatment before

3. There are measurable lesions according to the efficacy evaluation criteria for solid tumors (RECIST) version 1.1

4. ECOG score 0-2

5. Expected survival ≥3 months

6. LVEF≥55%

7. Bone marrow function: neutrophils ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥90g/L

8. 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

9. Thyroid function: normal range

10. Non-lactating patients

11. Sign the informed consent

Exclusion Criteria

1. Patients with previous PD-1 or PD-L1 treatment

2. Patients with previous abdominal or pelvic radiotherapy

3. Other malignant tumors other than cervical cancer appeared in the past 5 years

4. 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)

5. 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.)

6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation

7. Known allergy to any component of the drug

8. 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

9. Received other experimental drugs or participated in other drugs within 30 days of initial administration clinical research on the purpose of anticancer therapy

10. 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

11. Human immunodeficiency virus (HIV) positive

12. 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

13. Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) Antibody positive and HCV RNA positive

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Junjie Wang

Department director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Junjie Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University 3rd Hospital radiation oncology department

Locations

Peking University 3rd Hospital

Beijing, Beijng, China

Countries

China

Central Contacts

Ping Jiang, MD

Role: CONTACT

drjiangping@qq.com

010-82266699 ext. 4912

References

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.

Reference Type: DERIVED

PMID: 41087995 (View on PubMed)

Other Identifiers

M2019482

Identifier Type: -

Identifier Source: org_study_id