Camrelizumab Combined With Apatinib for Recurrent Resistant GTN

NCT04047017 | Completed Phase 2

• 1 other identifier: OBU-GTN-MUL-IIT-SHR1210-APA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the efficacy and safety of camrelizumab plus apatinib in patients with high-risk chemo-refractory or relapsed GTN.

Conditions

Gestational Trophoblastic Disease

Keywords

camrelizumab; apatinib; gestational trophoblastic neoplasia; high-risk; chemo-refractory; relapse

Outcome Measures

Primary Outcomes (1)

• ORR(objective response rate)

  the proportion of patients with complete or partial response according to serum hCG level

  Up to one years

Secondary Outcomes (4)

• DoR（duration of response）

  Up to one years

• PFS(progression free survival)

  Up to one years

• OS (overall survival)

  Up to one years

• Safety as measured by adverse events

  Up to one years

Study Arms (1)

Test group

EXPERIMENTAL

Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle. Apatinib :250 mg po qd

Drug: Apatinib; Drug: Camrelizumab

Interventions

Apatinib DRUG

250mg, po, qd

Test group

Camrelizumab DRUG

200mg, q2w

Test group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with recurrent resistant GTN previously received twice or more combination chemotherapy before enrolment;
• In the 20000 FIGO staging and classification, a risk score of 7 and above 7 (Considered high risk) or resistant recurrent placental site trophoblastic tumor or resistant recurrent epithelial trophoblastic tumor;
• Aged 18-70 years;
• An Eastern Cooperative Oncology Group performance status of 0-2;
• abnormal serum HCG level;
• Expected survival ≥ 4 months;
• The function of vital organs meets the following requirements： Hemoglobin≥80g/L; Absolute neutrophil count≥1.5\*109/L；Platelets≥100
• \*109/L; Creatinine≤1.5 times ULN; Urea nitrogen≤2.5 times ULN; Total Bilirubin≤ULN; ALT and AST ≤ 2.5 times ULN; Albumin≥25g/L; TSH≤ULN(if TSH is abnormal, normal T3 and T4 also can acceptable)
• Female subjects of childbearing age must exclude pregnancy and are willing to use a medically approved high-efficiency contraceptive (eg, IUD, contraceptive or condom) during the study period and within 3 months of the last study drug administration.
• The subject should be aware of the purpose of the study and the operations required by the study and volunteer to participate in the study before sign the informed consent form

You may not qualify if:

• Previously exposed to other anti-angiogenic small-molecule TKI drugs, such as pazopanib, sorafenib, regorafenib, cilnitraz, etc. or anti-angiogenic mAbs such as bevacizumab ; or had used an anti-PD-1 antibody, an anti-CTLA-4 antibody, TCR-T, CAR-T and other immune therapy; or 4 weeks before the first administration participated in any other clinical trials of anticancer drugs; or before the first dose Live attenuated vaccines are accepted within 4 weeks or during the study period.
• Other malignant tumors have occurred in the past 3 years..
• Immunosuppressive drugs used within 14 days prior to the first use of SHR-1210, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (ie, no more than 10 mg/day of turmeric or equivalent drug physiological dose) Other corticosteroids).
• Late-stage patients with symptomatic, disseminated to visceral, short-term risk of life-threatening complications (including uncontrolled large amounts of exudate \[thoracic, pericardium, abdominal cavity\], pulmonary lymphangitis, and more than 30% liver involvement patients).
• Any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, decreased thyroid function; subjects with vitiligo or complete remission asthma in childhood and without any intervention, all above can be included; asthma requiring medical intervention for bronchodilators should be excluded).
• Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite with the optimal medical treatment.
• Grade II or higher myocardial ischemia, myocardial infarction or poor control arrhythmia (including male with QTc interval ≥ 450ms, or female with QTc interval≥ 470ms). According to NYHA criteria, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) \<50%; myocardial infarction occurred within 6 months before enrollment, New York Heart Association Level II or above failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, pericardial disease with clinically significant, or electrocardiogram suggesting acute ischemia or abnormal active conduction system.
• Abnormal coagulation (INR \> 1.5 or prothrombin time (PT) \> ULN + 4 seconds or APTT \> 1.5ULN), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy.
• Half of a teaspoons (2.5 ml) or more hemoptysis was found within the first 2 months or there were significant clinical bleeding symptoms or clearly propensity bleeding within 3 months before participant in the study, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ or above in baseline or vasculitis; artery or venous thrombosis events within 6 months prior to the study, such as cerebrovascular accidents (Including transient ischemic attacks, cerebral hemorrhage, cerebral infarction, deep vein thrombosis and pulmonary embolism.
• Severe infections within 4 weeks prior to accept medication (eg, intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever during screening/first administration \>38.5 °C
• Those who have a history of psychotropic drug abuse and are unable to quit or have mental disorders.
• Major surgical procedures were performed within 4 weeks before the first administration. Or open wounds or fractures.
• There are obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction. Or sinus or perforation of empty organs within 6 months.
• Routine urine test indicated that urinary protein (++) or more, confirmed urinary protein (\>1.0 g) within 24 hours.
• Patients with a history of allergy may be potentially allergic or intolerant to Apatinib and biological agents SHR-1210.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

• Cheng H, Zong L, Kong Y, Wang X, Gu Y, Cang W, Zhao J, Wan X, Yang J, Xiang Y. Camrelizumab plus apatinib in patients with high-risk chemorefractory or relapsed gestational trophoblastic neoplasia (CAP 01): a single-arm, open-label, phase 2 trial. Lancet Oncol. 2021 Nov;22(11):1609-1617. doi: 10.1016/S1470-2045(21)00460-5. Epub 2021 Oct 5.

  PMID: 34624252 DERIVED

MeSH Terms

Conditions

Gestational Trophoblastic Disease; Recurrence

Interventions

apatinib; camrelizumab

Condition Hierarchy (Ancestors)

Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: August 4, 2019
• First Posted: August 6, 2019
• Study Start: August 8, 2019
• Primary Completion: March 18, 2021
• Study Completion: May 15, 2021
• Last Updated: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)