CClinicalTrials.gg
Status unknownNCT04368273CCRT+PD-1Updated Apr 29, 2020

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

A Phase 1/2 interventional study of PD-1 antibody in Cervical Cancer, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-04-29.

Sponsored by Peking University Third Hospital · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cervical Cancer

Keywords

  • PD-1
  • Radiotherapy
  • concurrent chemoradiotherapy
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 30 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    treatment

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

    Drug: PD-1 antibody

Interventions

  • DrugPD-1 antibody

    a new treatment drug combined radical radiotherapy concurrent chemotharpy

    Also known as: Toripalimab

06

What researchers measure

Primary outcomes

  1. Incidence and severity of acute adverse events

    safety evaluation

    Time frame: up to 3 months complete treatment

Secondary outcomes

  1. Objective response rate

    efficacy evaluation

    Time frame: 3 months later after treatment

  2. Progression-free survival

    efficacy evaluation

    Time frame: up to 2 years

07

Study locations

1 site
  • Peking University 3rd Hospital
    Beijing, Beijng 100191, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04368273
Lead sponsor
Peking University Third Hospital
Responsible party
Junjie Wang (Department director, Peking University Third Hospital) — Principal investigator
First posted
Apr 29, 2020
Start date
May 8, 2020 (estimated)
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Apr 29, 2020

Study contacts

Ping Jiang, MD
Contact
drjiangping@qq.com
010-82266699 ext. 4912
Junjie Wang, MD
principal investigator · Peking University 3rd Hospital radiation oncology department

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion