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Trial Title:
First-line Regimen With QL1706 Plus Chemo ± Bev in PDAC Patients
NCT ID:
NCT06313970
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Paclitaxel
Bevacizumab
Gemcitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QL1706
Description:
QL1706 5mg/kg,IV,D1, Q3W
Arm group label:
QL1706+chemotherapy
Arm group label:
QL1706+chemotherapy+ bevacizumab
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Nab-paclitaxel, 125mg/m2,IV,D1、8, Q3W
Arm group label:
QL1706+chemotherapy
Arm group label:
QL1706+chemotherapy+ bevacizumab
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
gemcitabine,1000mg/m2,IV,D1、8;Q3W.
Arm group label:
QL1706+chemotherapy
Arm group label:
QL1706+chemotherapy+ bevacizumab
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
bevacizumab, 7.5mg/kg,IV,D1;Q3W.
Arm group label:
QL1706+chemotherapy+ bevacizumab
Summary:
This is a multicenter, open-label, exploratory study to evaluate the efficacy and safety
of QL1706 plus nab-paclitaxel and gemcitabine with or without bevacizumab as first-line
treatment in patients with unresectable locally advanced or metastatic pancreatic cancer
Detailed description:
This study is an open, multicenter, exploratory clinical trial designed to evaluate the
efficacy and safety of QL1706 in combination with albumin paclitaxel and gemcitabine with
or without bevacizumab for the first-line treatment of patients with unresectable locally
advanced or metastatic pancreatic cancer.
The study was conducted in patients with unresectable locally advanced or metastatic
pancreatic cancer who had not received prior systemic therapy. Subjects sign informed
consent, undergo a screening period of examination and evaluation, which lasts for 21
days, and those who meet the entry criteria enter the treatment period and are randomized
1:1 to receive either QL1706 in combination with albumin paclitaxel and gemcitabine or to
receive QL1706 in combination with albumin paclitaxel, gemcitabine, and bevacizumab in
3-week intervals until protocol-specified treatment termination Event. Subjects will be
enrolled in the study and will undergo a safety visit prior to D1 dosing for each
treatment cycle, please refer to the trial flow chart. Imaging exams and assessments will
be performed every 6 weeks (± 7 days) for the first 24 weeks of treatment and every 9
weeks (± 7 days) thereafter until disease progression, initiation of new antitumor
therapy, withdrawal of informed consent, or death, whichever occurs first, as confirmed
per RECIST v1.1. Additional imaging and evaluation may be performed at any time during
the study if clinically indicated.
Subjects will be required to complete safety examinations and imaging assessments at the
end of treatment, followed by a safety visit and follow-up until 90 days after the last
dose of QL1706 or 30 days after the last dose of other investigational agents, whichever
is longer. For subjects who end treatment with non-RECIST v1.1 criteria for disease
progression, imaging should be continued to assess time to tumor progression. Survival
follow-up is performed after the safety visit, every 60 days (±7 days), to collect and
record the subject's survival status and subsequent antitumor therapy.
The study used ORR as the primary endpoint and was planned to enroll 50 subjects, 25 in
the QL1706 combined albumin paclitaxel and gemcitabine group and 25 in the QL1706
combined albumin paclitaxel and gemcitabine combined bevacizumab group.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects voluntarily participate in this study, sign the informed consent form;
2. Age ≥18 years and ≤75 years;
3. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or
adenocarcinoma.
4. Patients have not received prior systemic therapy for unresectable locally advanced
or metastatic pancreatic cancer;
5. At least one measurable lesion according to RECIST 1.1 criteria;
6. ECOG Performance Status 0-1;
7. Estimated life expectancy ≥3 months;
8. Adequate major organ function (no medication for blood component, cell growth factor
correction therapy is allowed within 14 days before randomization);
9. Women of child-bearing potential must agree to use a reliable, effective method of
contraception from the time they provide informed consent until at least 120 days
after the last dose of study drug is administered. HCG test must be negative. And
must be non-lactating;
10. Male participants whose partner is a woman of child-bearing potential must agree to
use a reliable, effective method of contraception from the time they sign an
informed consent form until at least 120 days after the last dose of study drug is
administered. Male subjects also have to agree not to donate sperm during the same
period.
Exclusion Criteria:
1. Histologically or cytologically confirmed other pathological types, such as acinar
cell carcinoma, pancreatic neuroendocrine neoplasms or pancreatoblastoma.
2. Patients with other malignant tumors within 5 years, except localized tumor that has
been cured;
3. Known active or untreated brain metastases, meningeal metastases, spinal cord
compression or leptomeningeal disease.
4. Patients with a history of life-threatening bleeding or a definite risk of bleeding
within 6 months before randomization;
5. Has undergone major trauma or surgical treatment within 28 days before randomization
or is expected to undergo major surgical treatment during the study period;
6. Poorly controlled hypertension (systolic blood pressure ≥140 mmHg and/or diastolic
blood pressure ≥90 mmHg) ;or have a history of hypertensive crisis or hypertensive
encephalopathy;
7. Thrombotic or embolic events, such as cerebrovascular accident (including transient
ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis,
pulmonary embolism, etc., occurred within 6 months before randomization;
8. Patients who receive any prior treatments targeting the mechanism of tumor immunity,
such as immune checkpoint blockades, immune checkpoint agonists, immune cell
therapy, etc.
9. Active autoimmune disease requiring systemic treatment within 2 years before
randomization, or autoimmune diseases that may relapse or require scheduled
treatment judged by the investigator;
10. Subjects with active hepatitis B or C;
11. Patients with a known history of immunodeficiency or HIV positive;
12. The investigator assessed that it is not appropriate to participate in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 15, 2024
Completion date:
April 15, 2026
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06313970