Cervical CancerPhase 1/2CCRT+PD-1NCT04368273
Pd-1 Antibody Combined CCRT for Local Advanced Cervical Cancer.
A Phase 1/2 study testing PD-1 antibody in people with Cervical Cancer, run by Peking University Third Hospital at 1 site in China.
Trial summary
To evaluate the safety and efficacy of anti-PD-1 (toripalimab) combined with cisplatin concurrent IMRT for locally advanced cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- PD-1 antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2020to 31 Dec 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Show all 11Show fewer
- 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
Who cannot join
- 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.)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Toripalimab Injection (Pd-1 Antibody) With Cisplatin Concurrent IMRT for Local Advanced Cervical Cancer.
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.
- Conditions
- Cervical Cancer
- Being tested
- PD-1 antibody
- Keywords
- PD-1, Radiotherapy, concurrent chemoradiotherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 antibodyDrug
Also called Toripalimab
a new treatment drug combined radical radiotherapy concurrent chemotharpy
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | PD-1 antibody combined CCRT for patients with local advanced cervical cancer. Receives: Drug: PD-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of acute adverse events
safety evaluation
Measured: up to 3 months complete treatment
Secondary outcomes (2)
Objective response rate
efficacy evaluation
Measured: 3 months later after treatment
Progression-free survival
efficacy evaluation
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start8 May 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junjie Wang, Peking University Third Hospital
- Investigators
- Junjie Wang, MD, Principal investigator, Peking University 3rd Hospital radiation oncology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368273
- Sponsor's protocol ID
- M2019482
- Acronym
- CCRT+PD-1
- Status last verified
- Apr 2020
- First submitted
- 25 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41087995
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Toripalimab Injection (Pd-1 Antibody) With Cisplatin Concurrent IMRT for Local Advanced Cervical Cancer.
- ClinicalTrials.gov ID
- NCT04368273
- Acronym / sponsor ID
- CCRT+PD-1 / M2019482
- Conditions
- Cervical Cancer
- Keywords
- PD-1, Radiotherapy, concurrent chemoradiotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 8 May 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: PD-1 antibodyPD-1 antibody combined CCRT for patients with local advanced cervical cancer. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-1 antibodyAlso: Toripalimaba new treatment drug combined radical radiotherapy concurrent chemotharpy | Drug | treatment |
Primary outcome
Incidence and severity of acute adverse events
Time frame: up to 3 months complete treatment
safety evaluation
2 secondary outcomes
Objective response rate
Time frame: 3 months later after treatment
Progression-free survival
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Derived from this study: PubMed 41087995Jiang 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.
Related trials for Cervical Cancer
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Endometrial Cancer, Cervical Cancer
RecruitingObservational study
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Cervical Cancer, Cervical Dysplasia
Recruiting
Use Misoprostol to Optimize Prevention of Cervical Cancer
Cervical Cancers
RecruitingPhase 4
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Cervical Cancer
RecruitingPhase 3
Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junjie Wang, MD principal investigator
Peking University 3rd Hospital radiation oncology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PD-1 antibody in people with Cervical Cancer, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping Jiang, MD (010-82266699 ext. 4912, drjiangping@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of acute adverse events (time frame: up to 3 months complete treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04368273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020; AzTrials last refreshed its copy on 6 Nov 2026.