Gastric CancersPhase 1/2NCT06766305
QL1706 Combined With SOX Used in Theperioperative Treatment
A Phase 1/2 study testing QL1706 combined with SOX in people with Gastric Cancers and Esophagogastric Junction Cancers, run by Xiangdong Cheng at 1 site in China.
Trial summary
This is a single-center, single-arm clinical study to evaluate the efficacy and safety of QL1706 combined with SOX for the treatment of resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancers, Esophagogastric Junction Cancers
- What is being tested?
- QL1706 combined with SOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2025to 30 Jun 2031
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign a written informed consent to join the study voluntarily;
- Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction;
- Adenocarcinoma of the stomach or gastroesophageal junction was evaluated by CT/MRI (primary clinical stage ≥T3 or N+, M0, according to AJCC 8th edition staging), including Siewert type II and III tumors
- Age 18-75 years old, male or female;
- ECOG PS 0-1 ;
- Have not received any anti-tumor treatment for gastric or gastroesophageal junction adenocarcinoma, including radiotherapy, chemotherapy, surgery, etc.;
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- Surgical treatment is planned after the completion of neoadjuvant therapy, and R0 resection is expected;
- Expected survival ≥6 months;
- Normal functioning of major organs, including:
- Blood routine examination (no blood component, cell growth factor are allowed within 7 days before the first use of the study drug) :
- neutrophil count ≥ 1.5×109/L Platelet count ≥ 80×109/L Hemoglobin ≥ 80 g/L
- Blood biochemical examination:
- Total bilirubin ≤ 1.5 x ULN ALT ≤ 2.5 x ULN, AST ≤ 2.5 x ULN, Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 mL/min (Cocheroft-Gault formula)
- Coagulation function:
- International Standardized ratio (INR) ≤ 1.5 x ULN Activated partial thromboplastin time (APTT) ≤ 1.5 x ULN
- Fertile female subjects are required to take a serum or urine pregnancy test that is negative within 72 hours prior to the start of the study drug administration, and to use effective contraception (such as Iuds, contraceptives, or condoms) during the trial period and for at least 120 days after the last dose; For male subjects whose partner is a fertile woman, they should be surgically sterilized or agree to use effective contraception during the trial and for 120 days after the last dose;
- The subject have good compliance and cooperated well with the follow-up
- Agreed to provide tumor tissue samples
Who cannot join
- There are unresectable factors, including unresectable tumor causes or unresectable or refused surgery contraindications;
- Have received or are receiving any of the following treatment:
- any radiation therapy, chemotherapy, or immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.) and other anti-tumor drugs;
- being treated with immunosuppressive drugs or systemic hormones for immunosuppressive purposes within 2 weeks prior to the initial use of the investigational drug (dose >10mg/ day prednisone or equivalent); In the absence of active autoimmune disease, inhaled or topical steroid use and adrenocortical hormone replacement with doses >10mg/ day of prednisone or equivalent are permitted;
- Received live attenuated vaccine within 4 weeks prior to the first use of the investigational drug; If enrolled, subjects must not receive live vaccine during the study period or within 120 days after the last administration of QL1706;
- Serious infections (CTCAE > Grade 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, and infection complications requiring hospitalization; Baseline chest imaging indicated active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except in cases of prophylactic antibiotic use;
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- Patients with active autoimmune disease requiring systemic treatment within 2 years prior to initial use of the investigational drug or a history of autoimmune disease with recurrence possible [including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (which can be controlled by hormone replacement therapy alone) Patients can be enrolled)];
- A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;
- There are clinical symptoms or diseases of heart that are not well controlled, including but not limited to: (1) NYHA grade II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) Clinically significant supraventricular or ventricular arrhythmias that are not well controlled without or after clinical intervention; (5) QTc> 450ms (male); QTc > 470ms (female);
- Patients found to have active pulmonary tuberculosis infection through medical history or CT examination, or had a history of active pulmonary tuberculosis infection within 1 year before enrollment, or had a history of active pulmonary tuberculosis infection more than 1 year ago without formal treatment;
- There are factors that increase the risk of prolonged QTc and abnormal heart rate, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, sudden unexplained death of immediate family members under 40 years of age, or prolonged QT interval accompanied by medication;
- Active hepatitis (Hepatitis B reference: HBsAg positive and HBV DNA≥2000 IU/ml; Hepatitis C reference: HCV antibody positive and HCV copy number > upper limit of normal);
- Defined as ≥ grade 2 peripheral neuropathy according to NCI-CTCAE v5.0 standards;
- Have been diagnosed with other malignancies within 5 years prior to initial dosing, unless malignancies with a low risk of metastasis or death (5-year survival > 90%), such as well-treated basal cell or squamous cell skin cancer of the skin or cervical carcinoma in situ may be considered for inclusion;
- Known history of severe hypersensitivity to other monoclonal antibodies; Patients with a known history of allergy or hypersensitivity to QL1706, oxaliplatin, and Tigor or any of their components;
- Known deficiency of dihydropyrimidine dehydrogenase;
- Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome that may affect the absorption of Tegor;
- Pregnant or lactating women;
- Enrolling in another clinical study at the same time, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study;
- The investigator determined that there were other factors that might have led to the forced termination of the study, such as other serious medical conditions (including mental illness) requiring co-treatment, alcohol, substance abuse, family or social factors, and factors that might have affected the safety or adhere
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, 1 recruiting
- Recruiting
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Hangzhou, Zhejiang, 310000
Xiangdong Cheng, PhD, +0086-0571 88128041, chengxd516@126.com
About this study
Official title: Phase Ib/II Clinical Study of QL1706 Combined With SOX Perioperative Treatment for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
This is a single-center, single-arm clinical study to evaluate the efficacy and safety of QL1706 combined with SOX for the treatment of resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
The study consists of the following two phases:
Read more
Phase 1: The safety introduction phase of QL1706 combined with SOX, using a 3+3 design, enrolled about 6 to 12 patients with locally advanced gastric/gastroesophageal junction adenocarcinoma (primary clinical stage ≥T3 or N+, M0) and underwent 3-week DLT evaluation.
Phase 2: This phase plans to enroll 42 to 45 patients, using investigator-evaluated pCR as the primary endpoint. QL1706 is administered by intravenous infusion of RP2D as defined in Part 1 starting from cycle 1.
Preoperative QL1706 RP2D combined with SOX (3 cycles) → radical surgery (D2) → postoperative QL1706 RP2D combined with SOX (5 cycles) → postoperative maintenance of QL1706 RP2D (up to 1 year before and after surgery); neoadjuvant therapy Surgery should be performed within 3 to 6 weeks after the last dosing, with a minimum interval of 4 weeks after surgery and a maximum interval of 6 weeks recommended for postoperative adjuvant therapy.
- Conditions
- Gastric Cancers, Esophagogastric Junction Cancers
- Being tested
- QL1706 combined with SOX
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706 combined with SOXDrug
QL1706 + SOX (3 cycles) before surgery → radical surgery (D2) → QL1706 + SOX (5 cycles) after surgery → QL1706 monotherapy maintenance （up to 1 year before and after surgery); Phase 1 (initial dose cohort) ： QL1706 5mg/kg ；Phase 1 (dose escalation cohort)：QL1706 7.5mg/kg ；Phase 2：QL1706 RP2D
| Study group | Role | What they receive |
|---|---|---|
| QL1706 combined with SOX | Experimental | QL1706 + SOX (3 cycles) before surgery → radical surgery (D2) → QL1706 + SOX (5 cycles) after surgery → QL1706 monotherapy maintenance (up to 1 year before and after surgery); Surgery is performed 3 - 6 weeks after the last dose of neoadjuvant therapy, and postoperative adjuvant therapy is initiated at least 4 weeks and up to 6 weeks after surgery.
Phase 1 (initial dose cohort) ： QL1706 5mg/kg ；Phase 1 (dose escalation cohort)：QL1706 7.5mg/kg ；Phase 2：QL1706 RP2D Receives: Drug: QL1706 combined with SOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
Measured: 21 days
Recommended Phase II Dose
Measured: 21 days
Pathological complete response
Measured: After operation about 2 weeks
Secondary outcomes (8)
major pathological response
Measured: After operation about 2 weeks
R0 resection rate
Measured: about 15 weeks
ypTNM stage
Measured: After operation about 2 weeks
Event-Free Survival
Measured: up to approximately 4 years
Disease-Free Survival
Measured: approximately 4 years
Overall survival
Measured: up to approximately 6 years
Surgery Delay
Measured: about 2 months，compared with surgery performed within 3 to 6 weeks after the last administration of neoadjuvant therapy
Incidence and severity of adverse events (including serious adverse events and immune-related adverse events) assessed by CTCAE v5.0
Measured: about 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start21 Mar 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancersStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangdong Cheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiangdong Cheng, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766305
- Sponsor's protocol ID
- QL-GasC-QIBA-1001
- Status last verified
- Jun 2025
- First submitted
- 28 Dec 2024
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: QL1706 + SOX (3 cycles) before surgery → radical surgery (D2) → QL1706 + SOX (5 cycles) after surgery → QL1706 monotherapy maintenance (up to 1 year before and after surgery); Surgery is performed 3 - 6 weeks after the last dose of neoadjuvant therapy, and postoperative adjuvant therapy is initiated at least 4 weeks and up to 6 weeks after surgery. Phase 1 (initial dose cohort) ： QL1706 5mg/kg ；Phase 1 (dose escalation cohort)：QL1706 7.5mg/kg ；Phase 1：QL1706 RP2D
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Clinical Study of QL1706 Combined With SOX Perioperative Treatment for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06766305
- Acronym / sponsor ID
- QL-GasC-QIBA-1001
- Conditions
- Gastric Cancers, Esophagogastric Junction Cancers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Xiangdong ChengUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 9 Jan 2025 (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, single-arm clinical study to evaluate the efficacy and safety of QL1706 combined with SOX for the treatment of resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
The study consists of the following two phases:
Phase 1: The safety introduction phase of QL1706 combined with SOX, using a 3+3 design, enrolled about 6 to 12 patients with locally advanced gastric/gastroesophageal junction adenocarcinoma (primary clinical stage ≥T3 or N+, M0) and underwent 3-week DLT evaluation.
Phase 2: This phase plans to enroll 42 to 45 patients, using investigator-evaluated pCR as the primary endpoint. QL1706 is administered by intravenous infusion of RP2D as defined in Part 1 starting from cycle 1.
Preoperative QL1706 RP2D combined with SOX (3 cycles) → radical surgery (D2) → postoperative QL1706 RP2D combined with SOX (5 cycles) → postoperative maintenance of QL1706 RP2D (up to 1 year before and after surgery); neoadjuvant therapy Surgery should be performed within 3 to 6 weeks after the last dosing, with a minimum interval of 4 weeks after surgery and a maximum interval of 6 weeks recommended for postoperative adjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QL1706 combined with SOX | Experimental | Drug: QL1706 combined with SOXQL1706 + SOX (3 cycles) before surgery → radical surgery (D2) → QL1706 + SOX (5 cycles) after surgery → QL1706 monotherapy maintenance (up to 1 year before and after surgery); Surgery is performed 3 - 6 weeks after the last dose of neoadjuvant therapy, and postoperative adjuvant therapy is initiated at least 4 weeks and up to 6 weeks after surgery. Phase 1 (initial dose cohort) ： QL1706 5mg/kg ；Phase 1 (dose escalation cohort)：QL1706 7.5mg/kg ；Phase 2：QL1706 RP2D |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Sign a written informed consent to join the study voluntarily;
- Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction;
- Adenocarcinoma of the stomach or gastroesophageal junction was evaluated by CT/MRI (primary clinical stage ≥T3 or N+, M0, according to AJCC 8th edition staging), including Siewert type II and III tumors
- Age 18-75 years old, male or female;
- ECOG PS 0-1 ;
Key exclusion criteria (20 listed)
- There are unresectable factors, including unresectable tumor causes or unresectable or refused surgery contraindications;
- Have received or are receiving any of the following treatment:
- Serious infections (CTCAE > Grade 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, and infection complications requiring hospitalization; Baseline chest imaging indicated active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except in cases of prophylactic antibiotic use;
- Patients with active autoimmune disease requiring systemic treatment within 2 years prior to initial use of the investigational drug or a history of autoimmune disease with recurrence possible [including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (which can be controlled by hormone replacement therapy alone) Patients can be enrolled)];
- A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;
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 |
|---|---|---|
| QL1706 combined with SOXQL1706 + SOX (3 cycles) before surgery → radical surgery (D2) → QL1706 + SOX (5 cycles) after surgery → QL1706 monotherapy maintenance （up to 1 year before and after surgery); Phase 1 (initial dose cohort) ： QL1706 5mg/kg ；Phase 1 (dose escalation cohort)：QL1706 7.5mg/kg ；Phase 2：QL1706 RP2D | Drug | QL1706 combined with SOX |
Primary outcome
Dose-limiting toxicity
Time frame: 21 days
Recommended Phase II Dose
Time frame: 21 days
Pathological complete response
Time frame: After operation about 2 weeks
8 secondary outcomes
major pathological response
Time frame: After operation about 2 weeks
R0 resection rate
Time frame: about 15 weeks
ypTNM stage
Time frame: After operation about 2 weeks
Event-Free Survival
Time frame: up to approximately 4 years
Disease-Free Survival
Time frame: approximately 4 years
Overall survival
Time frame: up to approximately 6 years
Surgery Delay
Time frame: about 2 months，compared with surgery performed within 3 to 6 weeks after the last administration of neoadjuvant therapy
Incidence and severity of adverse events (including serious adverse events and immune-related adverse events) assessed by CTCAE v5.0
Time frame: about 18 months
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 17 Jun 2025.
- Individual participant dataSharing planned: Yes. QL1706 + SOX (3 cycles) before surgery → radical surgery (D2) → QL1706 + SOX (5 cycles) after surgery → QL1706 monotherapy maintenance (up to 1 year before and after surgery); Surgery is performed 3 - 6 weeks after the last dose of neoadjuvant therapy, and postoperative adjuvant therapy is initiated at least 4 weeks and up to 6 weeks after surgery. Phase 1 (initial dose cohort) ： QL1706 5mg/kg ；Phase 1 (dose escalation cohort)：QL1706 7.5mg/kg ；Phase 1：QL1706 RP2D
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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 1/2 study testing QL1706 combined with SOX in people with Gastric Cancers and Esophagogastric Junction Cancers, run by Xiangdong Cheng 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 18 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 17 Jun 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Xiangdong Cheng (0086-571-881280, Chengxd516@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (time frame: 21 days). The study lists 3 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 17 Jun 2025.