Overview

QL1604 Plus Chemotherapy Versus Chemotherapy in Subjects With Stage ⅣB, Recurrent, or Metastatic Cervical Cancer

Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of PD-1 Inhibitor (QL1604) plus chemotherapy in patients with Stage Ⅳ, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin and paclitaxel plus carboplatin.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Treatments:
Carboplatin
Paclitaxel
Criteria
Inclusion Criteria:

1. Age ≥ 18 years and ≤ 75 years

2. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

3. Life expectancy of at least 12 weeks.

4. At least one measurable lesion (according to RECIST v1.1)

5. Cervical squamous cell carcinoma, adenocarcinoma and adenosquamous cell carcinoma
diagnosed by histopathology and confirmed by imaging as recurrent or stage ⅣB cervical
cancer.

6. No brain metastasis, or no meningeal metastasis.

7. Patients must have normal function as defined:

1. ANC≥1.5*10^9/L; PLT≥90*10^9/L, Hb≥90 g/L,

2. Total Bilirubin (TBIL)≤1.5*Upper Limit of Normal(ULN), Alanine Transaminase
(ALT)and Aspartate Aminotransferase(AST)≤2.5*ULN.For liver metastasis patients,
ALT and AST≤5*ULN,

3. Cr≤ 1.5*ULN, or creatinine clearance rate ≥50 mL/min,

4. Proteinuria <2+,if proteinuria≥ 2+ and 24 hours total urine protein < 1.0 g

5. LVEF≥ 50%.

8. Any unresolved AEs ≤ CTCAE Grade 1 (except alopecia).

9. Negative pregnancy test for females of child-bearing potentials.

10. Patients with reproductive function agreed to take effective contraceptive measures
during the treatment and in 6 months after the end of administration.

11. Patients must be able to understand and volunteer to sign the informed consent.

Exclusion Criteria:

1. Has received more than 2 courses of palliative chemotherapy for treatment of cervical
cancer.

2. Has received prior chemoradiotherapy within 3 months before enrollment,or has received
prior radiotherapy within 2 weaks before enrollment.

3. Has received prior surgery therapy within 2 weaks before enrollment,or has not
recovered from the effects of surgery therapy.

4. Is currently participating in or has participated in a study of an investigational
agent within 4 weeks before enrollment.

5. Has any active autoimmune diseases or a history of autoimmune diseases (such as the
following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis,
pituitary inflammation, vasculitis, nephritis, thyroid hyperfunction; patients with
vitiligo; complete remission of asthma in childhood, can be included without any
intervention after adulthood; asthma patients who require bronchodilators for medical
intervention cannot be included).

6. Is using immunosuppressive agents or systemic hormonal therapy to achieve
immunosuppressive purposes (agents amount > 10 mg / day of prednisone or other
therapeutic hormones), and continue to use within 2 weeks before enrollment.

7. Known history of hypersensitivity to macromolecular protein preparation or any
components of the QL1604 formulation, or any components of the study drugs.

8. Has uncontrolled clinically significant cardiac and cerebral vascular diseases within
6 months before enrollment, including but not limited to the following: myocardial
infarction, severe or unstable angina, coronary artery/peripheral artery bypass
grafting, congestive heart failure, cerebrovascular accident (including transient
ischemic attack).

9. Symptomatic congestive heart failure (New York Heart Association Grade II-IV), or
NCI-CTCAE v5.0 ≥ 2 arrhythmia, atrial fibrillation of any grade, or clinically
significant supraventricular arrhythmia or ventricular arrhythmia requirement for
treatment or intervention.

10. Has active infection or an unexplained fever > 38.5°C during screening visits(
subjects with tumor fever may be enrolled at the discretion of the investigator).

11. Hepatitis b surface antigen (HBsAg) positive and/or hepatitis b core antibody (HBcAb)
positive and HBVDNA>103copies/ml, hepatitis c virus antibody positive .

12. Known history of human immunodeficiency virus (HIV) infection, or other acquired or
congenital immunodeficiency diseases,or has a history of organ transplantation (except
corneal transplantation).

13. Has been vaccinated with live anti-tumor vaccine, or have received anti-tumor
immunotherapy, or may receive other systemic anti-tumor treatments during the study
period.

14. Peripheral neuropathy≥ CTCAE Grade 2.

15. History of psychotropic substance abuse, alcoholism or drug abuse.

16. Has a clear history of neurological or mental disorders, including epilepsy or
dementia.

17. Patients with other malignancies witnin 5 years( except cured basal cell carcinoma of
skin cancer, papillary thyroid carcinoma).

18. At the discretion of the investigator, there are patients with serious concomitant
disease that compromises patient safety or affects the patient's completion of the
study,such as unable to be controlled within normal level following treatment of
anti-hypertension agents (systolic blood pressure > 160 mmHg, diastolic blood pressure
> 110 mmHg), serious diabetes, thyroid diseases, etc.