Stomach NeoplasmsPhase 2NCT07920224
Candonilimab Combined With Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
A Phase 2 study testing candonilimab combined with fruquintinib and paclitaxel albumin-bound in people with Stomach Neoplasms, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This is a Phase II Study of Candonilimab Combined with Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for 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
- Stomach Neoplasms
- What is being tested?
- candonilimab combined with fruquintinib and paclitaxel albumin-bound
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2025to 1 Jun 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a full understanding of the study and voluntarily sign the informed consent form;
- Aged 18 to 75 years (inclusive);
- Pathologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma;
- Prior failure of first-line standard chemotherapy;
- HER2-negative status;
- ECOG performance status of 0 to 2;
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- Expected survival of ≥3 months;
- Presence of at least one measurable lesion, defined as:
- Longest diameter ≥10 mm as assessed by spiral CT scan;
- Diameter ≥20 mm as assessed by conventional CT scan(per Response Evaluation Criteria in Solid Tumors, RECIST version 1.1);
- Major organ function meeting the following requirements (use of any blood products or hematopoietic growth factors within 14 days prior to enrollment is not permitted):
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L;
- Platelet (PLT) count ≥100 × 10⁹/L;
- Hemoglobin (Hb) ≥90 g/L;
- Total bilirubin (TBIL) <1.5 × upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) <1.5 × ULN (or <3 × ULN for patients with liver metastases);
- Serum creatinine <1.5 × ULN;
- Creatinine clearance rate (CCr) ≥50 ml/min;
- Men and women of childbearing potential must agree to use effective contraceptive measures;
- Willingness to provide sufficient tumor tissue samples for PD-L1 expression testing.
Who cannot join
- Patients will be excluded from this study if they meet any of the following criteria:
- Inability to comply with the study protocol or study procedures;
- Prior treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or prior use of immune checkpoint inhibitors;
- History of other malignant tumors within the past 5 years, except for basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix after curative resection;
- Presence of central nervous system (CNS) metastases or history of brain metastases prior to enrollment;
- Diagnosis of autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;
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- Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- Uncontrolled malignant ascites (defined as ascites that cannot be controlled by diuretics or paracentesis as judged by the investigator);
- Severe cardiovascular diseases occurring within 6 months prior to the initiation of study treatment, including unstable angina pectoris or myocardial infarction; cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting (CABG) within 6 months prior to enrollment; congestive heart failure (CHF) with New York Heart Association (NYHA) classification > Grade 2; ventricular arrhythmias requiring medication; left ventricular ejection fraction (LVEF) < 50%;
- Subjects with known hypersensitivity to the study drugs or any of their excipients;
- Participation in other clinical trials of unapproved or unmarketed drugs in China and receipt of the corresponding investigational drug treatment within 4 weeks prior to enrollment;
- International Normalized Ratio (INR) > 1.5 or activated partial thromboplastin time (APTT) > 1.5 × upper limit of normal (ULN);
- Electrolyte abnormalities deemed clinically significant by the investigator;
- Uncontrolled hypertension (defined as systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg) that cannot be controlled with medications prior to enrollment;
- Poorly controlled diabetes mellitus prior to enrollment (fasting blood glucose concentration ≥ Common Terminology Criteria for Adverse Events [CTCAE] Grade 2 after standard treatment);
- Any disease or condition that may affect drug absorption prior to enrollment, or inability to take fruquintinib orally;
- Active peptic ulcers of the stomach and duodenum, ulcerative colitis, or other gastrointestinal diseases; active bleeding from unresected tumors; or other conditions judged by the investigator to potentially cause gastrointestinal bleeding or perforation prior to enrollment;
- Active or uncontrolled severe infections (≥ CTCAE v5.0 Grade 2 infections);
- Known human immunodeficiency virus (HIV) infection; known history of clinically significant liver disease, including viral hepatitis [subjects known to be hepatitis B virus (HBV) carriers must be excluded if they have active HBV infection, i.e., HBV DNA positive (> 1 × 10⁴ copies/mL or > 2000 IU/mL); known hepatitis C virus (HCV) infection with positive HCV RNA (> 1 × 10³ copies/mL)];
- Unresolved toxicities above CTCAE v5.0 Grade 1 resulting from any prior anticancer treatment, excluding alopecia, lymphopenia, and ≤ Grade 2 neurotoxicity caused by oxaliplatin;
- Pregnant females (positive pregnancy test prior to drug administration) or females who are breastfeeding;
- Receipt of blood transfusion, blood products, or hematopoietic factors (e.g., albumin, granulocyte colony-stimulating factor [G-CSF]) within 14 days prior to enrollment;
- Any other diseases, clinically significant metabolic abnormalities, physical examination abnormalities, or laboratory test abnormalities; conditions judged by the investigator to make the subject unsuitable for study drug administration (e.g., epilepsy requiring treatment), potentially interfere with the interpretation of study results, or place the subject at high risk;
- Urinalysis indicating urinary protein ≥ 2+ and 24-hour urinary protein excretion > 1.0 g;
- Complications requiring long-term immunosuppressive therapy, or systemic or local use of immunosuppressive corticosteroids (> 10 mg/day prednisone or equivalent therapeutic hormones);
- Subjects deemed unsuitable for enrollment in this study by the investigator.
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
Union Hospital
Wuhan, Hubei, 430030
Hongli Liu, +86-027-85871962, whxhzjy@hust.edu.cn
About this study
Official title: Single-Arm, Multicenter, Phase II Study of Candonilimab Combined With Fruquintinib With or Without Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First-Line Therapy Containing a PD-(L)1 Inhibitor
This is a Phase II Study of Candonilimab Combined with Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Read the detailed description
This study will enroll patients with advanced gastric or gastroesophageal junction adenocarcinoma who experienced disease progression on first-line PD-(L)1 inhibitor-containing therapy. Eligible patients will receive candonilimab combined with fruquintinib and paclitaxel albumin-bound as second-line treatment, and the combination therapy will be continued until disease progression, intolerable toxicity, withdrawal of informed consent, or achievement of the maximum treatment duration specified in the study protocol.
- Conditions
- Stomach Neoplasms
- Being tested
- candonilimab combined with fruquintinib and paclitaxel albumin-bound
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
candonilimab combined with fruquintinib and paclitaxel albumin-boundDrug
Candonilimab: 10 mg/kg every 3 weeks (Q3W) Fruquintinib: 4 mg orally once daily (qd), administered for 2 consecutive weeks followed by 1 week of rest Paclitaxel Albumin-Bound: 130 mg/m² on Day 1 and D
| Study group | Role | What they receive |
|---|---|---|
| candonilimab combined with fruquintinib and paclitaxel albumin-bound | Experimental | Candonilimab: 10 mg/kg Q3W Fruquintinib: 4 mg orally qd, administered for 2 consecutive weeks followed by 1 week of rest Paclitaxel Albumin-Bound: 130 mg/m² on Day 1 and Day 8 (D1, D8), every 3 weeks, for a total of 6 cycles Receives: Drug: candonilimab combined with fruquintinib and paclitaxel albumin-bound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1 and mRECIST.
Measured: from date of randomization until the date of progressive disease or EOT due to any cause, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start19 Jul 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- 59 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920224
- Sponsor's protocol ID
- AK104-GC006
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Arm, Multicenter, Phase II Study of Candonilimab Combined With Fruquintinib With or Without Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First-Line Therapy Containing a PD-(L)1 Inhibitor
- ClinicalTrials.gov ID
- NCT07920224
- Acronym / sponsor ID
- AK104-GC006
- Conditions
- Stomach Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 19 Jul 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 5 Nov 2026 (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 Phase II Study of Candonilimab Combined with Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Detailed description
This study will enroll patients with advanced gastric or gastroesophageal junction adenocarcinoma who experienced disease progression on first-line PD-(L)1 inhibitor-containing therapy. Eligible patients will receive candonilimab combined with fruquintinib and paclitaxel albumin-bound as second-line treatment, and the combination therapy will be continued until disease progression, intolerable toxicity, withdrawal of informed consent, or achievement of the maximum treatment duration specified in the study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| candonilimab combined with fruquintinib and paclitaxel albumin-bound | Experimental | Drug: candonilimab combined with fruquintinib and paclitaxel albumin-boundCandonilimab: 10 mg/kg Q3W Fruquintinib: 4 mg orally qd, administered for 2 consecutive weeks followed by 1 week of rest Paclitaxel Albumin-Bound: 130 mg/m² on Day 1 and Day 8 (D1, D8), every 3 weeks, for a total of 6 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Have a full understanding of the study and voluntarily sign the informed consent form;
- Aged 18 to 75 years (inclusive);
- Pathologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma;
- Prior failure of first-line standard chemotherapy;
- HER2-negative status;
Key exclusion criteria (26 listed)
- Inability to comply with the study protocol or study procedures;
- Prior treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or prior use of immune checkpoint inhibitors;
- History of other malignant tumors within the past 5 years, except for basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix after curative resection;
- Presence of central nervous system (CNS) metastases or history of brain metastases prior to enrollment;
- Diagnosis of autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;
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 |
|---|---|---|
| candonilimab combined with fruquintinib and paclitaxel albumin-boundCandonilimab: 10 mg/kg every 3 weeks (Q3W) Fruquintinib: 4 mg orally once daily (qd), administered for 2 consecutive weeks followed by 1 week of rest Paclitaxel Albumin-Bound: 130 mg/m² on Day 1 and D | Drug | candonilimab combined with fruquintinib and paclitaxel albumin-bound |
Primary outcome
Objective Response Rate (ORR)
Time frame: from date of randomization until the date of progressive disease or EOT due to any cause, assessed up to 1 year
ORR is defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1 and mRECIST.
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 5 Nov 2026.
- 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 candonilimab combined with fruquintinib and paclitaxel albumin-bound in people with Stomach Neoplasms, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 20 inclusion and 26 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 5 Nov 2026. 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 Hongli Liu (+86-027-85871962, whxhzjy@hust.edu.cn), 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: from date of randomization until the date of progressive disease or EOT due to any cause, assessed up to 1 year). 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 5 Nov 2026.