Gastric Cancer (GC)Phase 2NCT07045805
Phase II Study of QL1706 Combined With Paclitaxel and Bevacizumab for Second-Line Immune Rechallenge in Gastric Cancer
A Phase 2 study testing QL1706 combined with paclitaxel and bevacizumab in people with Gastric Cancer (GC), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
The study aims to evaluate the efficacy and safety of the QL1706 combination with paclitaxel and bevacizumab in patients with gastric adenocarcinoma and gastroesophageal junction adenocarcinoma who have failed first-line standard therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer (GC)
- What is being tested?
- QL1706 combined with paclitaxel and bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2025to 31 Mar 2028
- Phase
- Phase 2
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
- Signed written informed consent and voluntarily enrolled in the study.
- Aged 18-75 years, regardless of gender.
- Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
- Documented failure after ≥3 cycles of prior first-line PD-(L)1 inhibitor combined with fluorouracil-based or platinum-based chemotherapy.
- Note: Disease recurrence/progression ≤6 months after completing (neo)adjuvant systemic therapy qualifies as first-line treatment.
- HER2-negative status (IHC 0/1+ or IHC 2+/FISH-negative).
Show all 25Show fewer
- ECOG Performance Status 0-1.
- ≥1 measurable lesion per RECIST v1.1. Previously irradiated lesions cannot be target lesions unless: the irradiated lesion is the sole measurable lesion and documented progression in the irradiated lesion by imaging
- Life expectancy ≥3 months.
- Adequate organ function:
- Hematology (no blood products/growth factors within 14 days prior):
- Absolute neutrophil count ≥1.0×10⁹/L
- Platelets ≥75×10⁹/L
- Hemoglobin ≥90 g/L
- Biochemistry:
- Total bilirubin ≤1.5×ULN
- ALT/AST ≤2.5×ULN (≤5×ULN if liver metastases)
- Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min
- Coagulation:
- INR ≤1.5×ULN
- aPTT ≤1.5×ULN
- Reproductive requirements:
- Females of childbearing potential: Negative serum/urine pregnancy test within 72h prior to dosing; use effective contraception (IUD/oral contraceptives/condoms) during treatment and ≥120 days post-last dose.
- Males with fertile partners: Surgical sterilization or agreement to use effective contraception during treatment and ≥120 days post-last dose.
- Willingness to comply with protocol-specified follow-up procedures.
Who cannot join
- Histopathological or cytological examination confirms the presence of other pathological components, such as squamous cell carcinoma, undifferentiated carcinoma, neuroendocrine carcinoma, etc.
- Previous systemic treatment targeting VEGF or the anti-VEGFR signaling pathway.
- Previous treatment with PD-1/CTLA-4 dual immunotherapy.
- Previous systemic or local treatment with paclitaxel-based drugs.
- Received the last anti-tumor therapy within 5 half-lives (whichever is shorter) prior to the first dose, including chemotherapy, immunotherapy, targeted therapy (within 2 weeks prior to the first dose for small molecule targeted therapy), biological therapy, etc.; Palliative local therapy for non-target lesions within 2 weeks prior to the first dose; Received systemic non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin) within 2 weeks prior to the first dose.
- History of Grade 3 or higher irAEs (excluding endocrine system-related irAEs) caused by PD-1/PD-L1 inhibitors.
Show all 30Show fewer
- Permanent discontinuation of previous treatment due to irAEs.
- Has not adequately recovered (i.e., ≤ Grade 1 or returned to baseline, excluding fatigue or alopecia) from toxicities and/or complications caused by any prior intervention prior to starting treatment.
- Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥1 time/month).
- Known active or untreated brain metastases, leptomeningeal metastases, spinal cord compression, or leptomeningeal disease. However, subjects with measurable disease outside the central nervous system who meet the following criteria may be enrolled: asymptomatic after treatment, radiologically stable for at least 4 weeks prior to initiation of study treatment (e.g., no new or enlarging brain metastases), and off systemic glucocorticoids and anticonvulsants for at least 2 weeks.
- History of gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess within 6 months prior to the first dose.
- History of bowel obstruction and/or clinical signs or symptoms of gastrointestinal obstruction within 6 months prior to the first dose, including incomplete obstruction related to the underlying disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding.
- Significant clinically significant bleeding symptoms or definite bleeding tendency within 6 months prior to the first dose, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis, etc., excluding asymptomatic occult blood-positive stool.
- Tumor invasion of major blood vessels, or investigator judgment based on imaging that tumor invasion of major blood vessels is highly likely during the future study period, potentially leading to fatal hemorrhage.
- Arterial or venous thromboembolic events within 6 months prior to the first dose, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, etc. (superficial venous thrombosis is allowed).
- Major surgery (as determined by the investigator), open biopsy, or significant trauma within 28 days prior to the first dose; or planned elective major surgery during the study period.
- Urinalysis indicates urine protein ≥ ++ and confirmed 24-hour urine protein > 1.0 g.
- Hypertension that cannot be adequately controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); History of hypertensive crisis or hypertensive encephalopathy.
- Serious infection (CTCAE > Grade 2) within 4 weeks prior to the first study drug dose, such as severe pneumonia requiring hospitalization, bacteremia, or complicated infections; Active pulmonary inflammation indicated by baseline chest imaging; Signs/symptoms of infection within 14 days prior to the first dose or requiring oral/intravenous antibiotics (excluding prophylactic antibiotic use).
- Any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered if controlled with hormone replacement therapy); Subjects with psoriasis or childhood asthma/allergies in complete remission without adult intervention may be considered; patients requiring medical intervention with bronchodilators are excluded.
- History of immunodeficiency, including positive HIV test, or other acquired/congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation.
- Poorly controlled cardiac clinical symptoms or diseases, including but not limited to: (1) NYHA Class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias uncontrolled without or despite clinical intervention; (5) QTc > 450ms (male); QTc > 470ms (female).
- Active tuberculosis infection identified by history or CT scan, or history of active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year ago without formal treatment.
- Active hepatitis (Hepatitis B reference: HBsAg positive and HBV DNA ≥2000 IU/mL; Hepatitis C reference: HCV antibody positive and HCV RNA > upper limit of normal).
- Diagnosed with other malignancies within 5 years prior to the first study drug dose, except for malignancies with low risk of metastasis or death (5-year survival rate > 90%), such as adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix, etc., who may be considered for enrollment.
- Received live attenuated vaccines within 4 weeks prior to the first study drug dose; If enrolled, subjects must not receive live vaccines during the study or within 120 days after the last dose of eplonolimab tovorilimab.
- Known allergy or intolerance to any study drug(s) and/or any excipients.
- Pregnant or lactating women.
- Currently participating in another clinical study, unless it is an observational, non-interventional study or in the follow-up period of an interventional study.
- Other factors that, in the investigator's judgment, may lead to premature termination from the study, such as other severe diseases (including psychiatric disorders) requiring combined treatment, alcoholism, drug abuse, familial or social factors, or any other factors affecting subject safety or compliance.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase II Study of Iparomlimab and Tuvonralimab Combined With Paclitaxel and Bevacizumab for the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma That Failed First-Line Treatment With PD-(L)1 Inhibitor Combined With Chemotherapy
The study aims to evaluate the efficacy and safety of the QL1706 combination with paclitaxel and bevacizumab in patients with gastric adenocarcinoma and gastroesophageal junction adenocarcinoma who have failed first-line standard therapy.
- Conditions
- Gastric Cancer (GC)
- Being tested
- QL1706 combined with paclitaxel and bevacizumab
- 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 paclitaxel and bevacizumabDrug
Phase 1:
Plan to enroll 6 subjects to receive QL1706 7.5 mg/kg, paclitaxel 150 mg/m², and bevacizumab 7.5 mg/kg, d1, Q3W. Subjects will undergo a 3-week Dose-Limiting Toxicity (DLT) evaluation period.
If ≥2 DLTs occur among the 6 subjects, QL1706 5 mg/kg will be selected as the Recommended Phase 2 Dose (RP2D) for Phase 2.
Otherwise, QL1706 7.5 mg/kg will be the RP2D for Phase 2.
Phase 2:
Plan to enroll 54-60 subjects. Starting from Cycle 1, QL1706 will be administered intravenously at the RP2D determined in Phase 1. Subjects will receive:
QL1706 (RP2D) Paclitaxel 150 mg/m² Bevacizumab 7.5 mg/kg All agents administered on day 1 of each Q3W cycle. Treatment Duration for All Subjects: Continues until disease progression, intolerable toxicity, withdrawal of informed consent, death, or initiation of new antitumor therapy-whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| QL1706 combined with paclitaxel and bevacizumab | Experimental | QL1706 7.5 or 5 mgmg/kg combined with paclitaxel 150 mg/m2 and bevacizumab 7.5mg/kg, d1, Q3W Receives: Drug: QL1706 combined with paclitaxel and bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
The time from the initiation of the first dose to the occurrence of disease progression or death, whichever comes first.
Measured: up to 7 months
Dose-limiting toxicity
Measured: Within Cycle 1 (21 days)
Secondary outcomes (4)
OS
The time interval between the start date of study drug and the date of death (any cause)
Measured: up to 13 months
DoR
monitor the length of time patients experience a reduction in tumor size or stabilization of disease following the treatment
Measured: up to 6 months
ORR
the proportion of subjects achieving complete response (CR) or partial response (PR)
Measured: up to 7 months
AE
Number and percentage of participants with Adverse Events(any grade)
Measured: the first dose until 90 days after the last dose of QL1706 or 30 days after the last dose of other study drugs, whichever comes later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start25 Jul 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia Wei, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045805
- Sponsor's protocol ID
- QL-GasC-QIBA-1002
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No