Pancreatic AdenocarcinomaPhase 2NCT06750861
QL1706 Plus Chemotherapy With AG Regime as First-line Treatment of Advanced PDAC
A Phase 2 study testing QL1706 in people with Pancreatic Adenocarcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a single-center, open-label, exploratory study to evaluate the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- QL1706
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18, male or female;
- Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
- Has not received prior systemic treatment for their locally advanced or metastatic PDAC;
- Has presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1);
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
- Has a life expectancy of at least 3 months;
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- Has adequate organ function;
- If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment;
- If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment.
Who cannot join
- Untreated active CNS metastasis or leptomeningeal metastasis.
- Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
- Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first trial treatment;
- Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
- Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment;
- Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to < 10 mg prednisone daily, inhaled steroids and topical use of steroids);
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- Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines);
- Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;
- History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent；
- Previous malignant disease History of uncontrolled intercurrent illness Prior therapy with any antibody/drug targeting T cell coregulatory proteins Known severe hypersensitivity reactions to antibody drug；
- Is pregnant or breastfeeding;
- Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Chaoyang District, 100021
Lin Yang, 8610-87788145, linyangcicams@126.com
About this study
Official title: QL1706 in Combination With Nab-paclitaxel and Gemcitabine as First-line Treatment in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma : A Single-arm, Phase II Study
This is a single-center, open-label, exploratory study to evaluate the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma.
Read the detailed description
This study is an open, single-center, exploratory clinical trial designed to evaluate the efficacy and safety of QL1706 in combination with nab-paclitaxel and gemcitabine for the first-line treatment of patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma, 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 receive QL1706 in combination with albumin-paclitaxel and gemcitabine in 3-week intervals until protocol-specified treatment termination Event. Subjects will be enrolled in the study and wil undergo safety visit prior to D1 dosing for each treatment cycle. lmaging exams and assessments will be performed every 6 weeks (± 7 days) until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, or death, whichever occurs first, as confirmed per REClST v1.1. Additional imaging and evaluation may be performed at any time during the study if clinically indicated.
Subjects wil 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. 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 anti-tumor therapy.The study used ORR as the primary endpoint and was planned to enroll 30 subjects.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- QL1706
- Keywords
- QL1706, Efficacy, Pancreatic cancer, Safety, Chemotherapy, First-Line
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706Drug
QL1706+AG
| Study group | Role | What they receive |
|---|---|---|
| QL1706+AG | Experimental | QL1706+AG
Every 3 weeks as a cycle:
QL1706: 5mg/kg, IV, D3; Q3W Nab-paclitaxel: 125mg/m2, IV，D1、8; Q3W Gemcitabine: 1000mg/m2，IV，D1、8; Q3W Re-evaluate patients every two cycles. If the patient has been treated for more than 8 cycles, they will enter maintenance therapy, and the regimen is QL1706 monotherapy. Receives: Drug: QL1706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR of regimen of QL1706+AG
Measured: 1 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The incidence and severity (graded by CTCAE 5.0) of treatment emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs), immune-related adverse events ( irAEs).
Measured: 1 year
Secondary outcomes (4)
Median Progression-Free Survival (mPFS)
Measured: 1 year
Median Overall Survival (mOS)
Measured: 2 years
Duration of Response (DoR)
Measured: 1 year
Disease Control Rate (DCR)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start15 Feb 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIN YANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750861
- Sponsor's protocol ID
- NCC5035
- Status last verified
- Feb 2025
- First submitted
- 20 Dec 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QL1706 in Combination With Nab-paclitaxel and Gemcitabine as First-line Treatment in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma : A Single-arm, Phase II Study
- ClinicalTrials.gov ID
- NCT06750861
- Acronym / sponsor ID
- NCC5035
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- QL1706, Efficacy, Pancreatic cancer, Safety, Chemotherapy, First-Line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Dec 2024 (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.
This is a single-center, open-label, exploratory study to evaluate the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma.
Detailed description
This study is an open, single-center, exploratory clinical trial designed to evaluate the efficacy and safety of QL1706 in combination with nab-paclitaxel and gemcitabine for the first-line treatment of patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma, 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 receive QL1706 in combination with albumin-paclitaxel and gemcitabine in 3-week intervals until protocol-specified treatment termination Event. Subjects will be enrolled in the study and wil undergo safety visit prior to D1 dosing for each treatment cycle. lmaging exams and assessments will be performed every 6 weeks (± 7 days) until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, or death, whichever occurs first, as confirmed per REClST v1.1. Additional imaging and evaluation may be performed at any time during the study if clinically indicated.
Subjects wil 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. 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 anti-tumor therapy.The study used ORR as the primary endpoint and was planned to enroll 30 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QL1706+AG | Experimental | Drug: QL1706QL1706+AG Every 3 weeks as a cycle: QL1706: 5mg/kg, IV, D3; Q3W Nab-paclitaxel: 125mg/m2, IV，D1、8; Q3W Gemcitabine: 1000mg/m2，IV，D1、8; Q3W Re-evaluate patients every two cycles. If the patient has been treated for more than 8 cycles, they will enter maintenance therapy, and the regimen is QL1706 monotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18, male or female;
- Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
- Has not received prior systemic treatment for their locally advanced or metastatic PDAC;
- Has presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1);
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
Key exclusion criteria (12 listed)
- Untreated active CNS metastasis or leptomeningeal metastasis.
- Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
- Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first trial treatment;
- Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
- Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment;
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 |
|---|---|---|
| QL1706QL1706+AG | Drug | QL1706+AG |
Primary outcome
Objective Response Rate (ORR)
Time frame: 1 year
ORR of regimen of QL1706+AG
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 1 year
The incidence and severity (graded by CTCAE 5.0) of treatment emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs), immune-related adverse events ( irAEs).
4 secondary outcomes
Median Progression-Free Survival (mPFS)
Time frame: 1 year
Median Overall Survival (mOS)
Time frame: 2 years
Duration of Response (DoR)
Time frame: 1 year
Disease Control Rate (DCR)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QL1706 in people with Pancreatic Adenocarcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 9 inclusion and 12 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: opening soon, as of the sponsor's last update on 10 Feb 2025. 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Yang, Doctor (13681015148, linyangcicams@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2025.