Actively Recruiting

Phase 2
Age: 18Years - 60Years
FEMALE
NCT05139095

Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia

Led by Peking Union Medical College Hospital · Updated on 2026-02-05

70

Participants Needed

1

Research Sites

257 weeks

Total Duration

On this page

Sponsors

P

Peking Union Medical College Hospital

Lead Sponsor

J

Jiangsu HengRui Medicine Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the efficacy and safety of camrelizumab and apatinib as combination therapy in patients with ultra high-risk (Cohort A) and high-risk chemo-refractory or relapsed (Cohort B) gestational trophoblastic neoplasia (GTN). Eligible patients will receive camrelizumab plus apatinib plus chemotherapy. Treatment will be continued until disease progression, unacceptable toxicity, or withdrawal of consent.

CONDITIONS

Official Title

Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia

Who Can Participate

Age: 18Years - 60Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Woman aged 18-60 years
  • Previously untreated ultra high-risk GTN (Cohort A) or high-risk chemo-refractory or relapsed GTN (Cohort B)
  • No previous chemotherapy or radiotherapy for ultra high-risk GTN (Cohort A)
  • Have received two or more lines of combination chemotherapy for high-risk chemo-refractory or relapsed GTN (Cohort B)
  • Ultra high-risk GTN patients with FIGO stages I-III and score 3 and stage IV (Cohort A)
  • Prognostic score 7 (Cohort B)
  • ECOG performance status of 0-1
  • Abnormal serum hCG level (5 IU/L)
  • Expected survival of at least 4 months
  • Vital organ function within specified laboratory limits
  • Female patients of childbearing age must exclude pregnancy and agree to use high-efficiency contraception during the study and for 6 months after
  • Willingness and ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Previous treatment with immunotherapy, anti-angiogenic tyrosine kinase inhibitors, or anti-angiogenic monoclonal antibodies
  • Received live vaccines within 4 weeks before study drug
  • Participation in other antitumor drug clinical trials within 4 weeks before study drug
  • Use of immunosuppressive drugs within 14 days before camrelizumab
  • Active or history of autoimmune disease
  • Uncontrolled hypertension despite treatment
  • Significant heart disease, including recent myocardial ischemia or infarction, arrhythmias, heart failure, or abnormal heart function
  • Abnormal blood clotting or bleeding disorders
  • Severe infections or unexplained fever within 4 weeks before study drug
  • History of drug abuse or mental disorders
  • Major surgery within 4 weeks before study drug or open wounds or fractures
  • Conditions affecting oral drug absorption or recent gastrointestinal surgery
  • Significant proteinuria
  • HIV infection or active hepatitis B or C
  • Any other reason judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, China

Actively Recruiting

Loading map...

Research Team

Y

Yang Xiang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here