Gastric Cancer or Gastroesophageal Junction AdenocarcinomaFREEDOMNCT07552402
Oral Paclitaxel Plus Fruquintinib Verus Investigator's Choice in Second-Line Advanced Gastric Cancer
A study testing Oral Paclitaxel Solution Plus Fruquintinib and Investigator Choice (IC) Chemotherapy in people with Gastric Cancer or Gastroesophageal Junction Adenocarcinoma, run by Harbin Medical University at 15 sites in China.
Trial summary
The goal of this study is to evaluate the efficacy and safety of oral paclitaxel solution plus fruquintinib as second-line therapy in adult subjects with advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Oral Paclitaxel Solution Plus Fruquintinib and Investigator Choice (IC) Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 15 sitesChina
- Study dates
- 10 Jun 2026to 30 Dec 2028
- Phase
- Interventional
- 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
- Age 18 to 75 years, regardless of sex;
- Histologically and/or cytologically confirmed advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has failed first-line therapy or developed intolerable toxicity to first-line treatment.
- Presence of at least one measurable lesion per RECIST v1.1 criteria (Note: Previously irradiated lesions cannot be used as target lesions unless unequivocal progression of the lesion after radiotherapy is documented);
- Body weight ≥40 kg or BMI >18.5 kg/m²;
- No severe hematologic, hepatic, or renal abnormalities:
- Hematology: Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet count (PLT) ≥100×10⁹/L; Hemoglobin (Hb) ≥90 g/L;
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- Chemistry: Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); ALT and AST ≤2.5×ULN in the absence of liver metastases, or ≤5×ULN if liver metastases are present; Serum creatinine (Cr) ≤1.5×ULN;
- Urinalysis: Urine protein ≤1+; If urine protein is ≥2+, a 24-hour urine protein test must be performed, and enrollment is permitted only if the 24-hour urine protein is <1.0 g;
- ECOG Performance Status (PS) 0-1;
- Life expectancy ≥12 weeks;
- Signed informed consent.
Who cannot join
- Known HER2-positive status without prior anti-HER2 therapy (patients who progressed after anti-HER2 therapy are eligible);
- History of another primary malignancy within 3 years prior to the first study drug administration, except for adequately treated basal cell or squamous cell carcinoma of the skin, or in situ carcinomas of the cervix, breast, or other sites;
- Receipt of radiotherapy (except palliative radiotherapy), chemotherapy, or small-molecule targeted anticancer therapy within 4 weeks or within 5 half-lives of the agent (whichever is shorter) prior to the first dose of study drug. Patients who discontinued other investigational agents for more than 5 half-lives are eligible for screening. Additionally, treatment with large-molecule targeted anticancer agents within 4 weeks prior to the first study drug dose is prohibited;
- Toxicity from prior anticancer therapy not recovered to ≤ Grade 1 or baseline levels (except alopecia; neurotoxicity must have resolved to ≤ Grade 2) within 2 weeks prior to the first study drug administration;
- Presence of dysphagia, uncontrolled nausea, vomiting, diarrhea, or known malabsorption syndrome that may interfere with oral drug absorption;
- Active gastrointestinal conditions such as gastric/duodenal ulcer, ulcerative colitis, or bowel obstruction, or any other condition deemed by the investigator to carry a risk of gastrointestinal hemorrhage or perforation; history of gastrointestinal perforation or fistula within the past 6 months; or incomplete recovery from surgery related to gastrointestinal perforation or fistula;
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- Evidence of significant bleeding or history of bleeding (e.g., hematemesis, hemoptysis) within 2 months prior to randomization. Patients with melena and positive fecal occult blood test must undergo gastroenteroscopy to rule out active bleeding or active ulcer before enrollment;
- Requirement for long-term use of proton pump inhibitors (PPIs) or H2-receptor antagonists during the trial; or use of strong inducers or inhibitors of cytochrome P450 (CYP) 3A4 or CYP2C8 within 2 weeks prior to the first study drug dose;
- Known active central nervous system (CNS) metastases and/or leptomeningeal carcinomatosis;
- Active infections or serious infectious diseases, including but not limited to: HIV infection (positive HIV antibody), active hepatitis (active HCV infection defined as positive HCV RNA; HCV antibody-positive but RNA-negative patients are allowed), active HBV infection (HBsAg-positive with HBV DNA >2000 IU/mL), bacteremia, severe pneumonia requiring systemic therapy, or active tuberculosis;
- Any of the following cardiovascular conditions: myocardial infarction, unstable angina, congestive heart failure (New York Heart Association Class ≥2), or other clinically significant cardiac disease within 6 months prior to the first study drug dose; clinically significant ECG abnormalities (e.g., arrhythmias, QTc interval >450 ms); left ventricular ejection fraction (LVEF) <50% on echocardiography; or uncontrolled hypertension despite treatment with ≥2 antihypertensive agents (systolic BP >140 mmHg or diastolic BP >90 mmHg);
- Prior systemic therapy targeting VEGF or VEGFR; or prior treatment with paclitaxel, docetaxel, nab-paclitaxel, liposomal paclitaxel, or polymeric micelle paclitaxel;
- Known hypersensitivity to any component of the investigational product;
- Pregnant or lactating women;
- Uncontrolled symptomatic pleural, peritoneal, or pericardial effusion requiring repeated drainage. Asymptomatic patients with minimal effusions detected only on imaging and who have not received drainage or other intervention within 2 weeks prior to enrollment are eligible;
- Major surgery (e.g., craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to first dosing, or presence of non-healed surgical wounds, ulcers, or fractures. Patients may be enrolled if the investigator determines they are fit to receive study drug ≥2 weeks post-surgery;
- History of deep vein thrombosis, pulmonary embolism, or other significant thromboembolic events within 3 months prior to study entry; ongoing anticoagulation therapy with warfarin, low-molecular-weight heparin, or similar agents. Prophylactic low-dose anticoagulation is permitted if INR ≤1.5 per inclusion criteria;
- Chronic use of nonsteroidal anti-inflammatory drugs (e.g., indomethacin, ibuprofen) or antiplatelet agents (e.g., clopidogrel, ticlopidine, dipyridamole). Low-dose aspirin (≤325 mg/day) is allowed;
- Any other condition deemed by the investigator as unsuitable for participation in this study.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
Baotou Cancer Hospital
Baotou, Inner Mongolia
Yaqin Tan, 86-15848806353, tanyaqin@csco.ac.cn
- Recruiting
Peking University Third Hospital
Beijing
Yu Xiao, +86 13001209322, xy2007111@126.com
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Qiancheng Hu, +86 17780026135, hqch860109@163.com
- Recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning
Tao Wu, 86-17709872828, wiyihong97@163.com
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Xiaoyan Lin, +86 133 6591 0793, 13950482366@qq.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Jieer Ying, 13858195803, jieerying@aliyun.com
- Recruiting
The Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Yanqiao Zhang, 86-138 4512 0210, yanqiaozhang@ems.hrbmu.edu.cn
Dan Su
- Recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia
Caixia Liu, +86-18847189559, lcxzhg1974@163.com
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Jie Ma, +86 13978851892, majie086@163.com
- Recruiting
The First Affiliated Hospital of Qiqihar Medical College
Qiqihar, Heilongjiang
Baisong Lou, 13604521696, 13604521696@qq.com
- Recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Xiuying Xiao, +86 135 6457 9313, xiaoxiuying2002@163.com
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Shengmian Li, 13931185237, shengmianli2013@163.com
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou
Yusong Zhang, +86 15952427001, zhangyusong19@163.com
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Hongli Liu, +86 13995680822, hongli_liu@hust.edu.cn
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan
Ping Chen, +86 13519295282, chenping2536@qq.com
About this study
Official title: Paclitaxel Oral Solution Plus Fruquintinib Versus Investigator's Choice as Second-Line Treatment for Advanced Gastric Cancer: A Multicenter, Open-Label, Randomized Controlled Trial
The goal of this study is to evaluate the efficacy and safety of oral paclitaxel solution plus fruquintinib as second-line therapy in adult subjects with advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) cancer.
- Being tested
- Oral Paclitaxel Solution Plus Fruquintinib, Investigator Choice (IC) Chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Paclitaxel Solution Plus FruquintinibDrug
Patients received oral paclitaxel plus fruquintinib in 4-week cycles until disease progression, death, unacceptable toxicity, withdrawal of consent, iscontinuation by the investigator or study completion or termination.
Investigator Choice (IC) ChemotherapyDrug
Investigator' choice of chemotherapy is given until disease progression, death, unacceptable toxicity, withdrawal of consent, iscontinuation by the investigator or study completion or termination.
| Study group | Role | What they receive |
|---|---|---|
| Oral Paclitaxel Solution Plus Fruquintinib | Experimental | Oral paclitaxel solution: 200mg/m2, p.o., bid, on days 1, 8, and 15 of each 28-day cycle.
Fruquintinib: 4 mg orally once daily, 3 weeks on/1week off Receives: Drug: Oral Paclitaxel Solution Plus Fruquintinib |
| Investigator-Selected Chemotherapy | Active comparator | Investigator-selected chemotherapy includes injectable taxanes (paclitaxel injection, albumin-bound paclitaxel, docetaxel, etc.), irinotecan, etc., excluding oral paclitaxel solution. Regimens and doses shall be determined by the investigator in accordance with recommendations from current clinical guidelines. Receives: Drug: Investigator Choice (IC) Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival（PFS）
Progression-free survival (PFS) is defined as the time from the date of randomization to disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.
Measured: assessed up to 1 year
Secondary outcomes (5)
Objective response rate（ORR）
ORR is defined as the percentage of subjects who have a Complete Response (CR) or Partial Response (PR) per RECIST 1.1
Measured: assessed up to 1 year
Disease Control Rate（DCR）
DCR is defined as the proportion of subjects whose BOR is rated as CR, PR, or stable disease (SD) per RECIST 1.1
Measured: assessed up to 1 year
Overall survival（OS）
OS is defined as the time from the date of randomization to the date of death, regardless of the cause of death.
Measured: From randomization until death due to any cause, up to 3 years.
Adverse event
Use NCI-CTCAE version 5.0 for classification and grading.
Measured: From first dose to 30 days post the last dose
Qualtiy of life assesd by EORTC QLQ-C30 v3.0
EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures global health status. There are 30 items in total, which can be divided into 15 fields. Five functional scales: physical function, role function, cognitive function, emotional function, social function; Three symptom scales: fatigue, pain, nausea and vomiting; Six individual measures: dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties, and a global quality of life scale. The five functional scales and the global quality of life scale were scored independently. After linear transformation, the scores of all items ranged from 1 to 100, and the higher score, the higher functional level. The symptom scale was also scored independently and linearly transformed into a score from 1 to 100, with higher scores indicating more serious problems or symptoms.
Measured: Evaluation from baseline to the 30 days post the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start10 Jun 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 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 or Gastroesophageal Junction AdenocarcinomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqiao Zhang, The Second Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552402
- Sponsor's protocol ID
- OT-2005-002
- Acronym
- FREEDOM
- Status last verified
- Jun 2026
- First submitted
- 13 Apr 2026
- Last updated
- 28 Oct 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel Oral Solution Plus Fruquintinib Versus Investigator's Choice as Second-Line Treatment for Advanced Gastric Cancer: A Multicenter, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07552402
- Acronym / sponsor ID
- FREEDOM / OT-2005-002
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 27 Apr 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.
The goal of this study is to evaluate the efficacy and safety of oral paclitaxel solution plus fruquintinib as second-line therapy in adult subjects with advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Paclitaxel Solution Plus Fruquintinib | Experimental | Drug: Oral Paclitaxel Solution Plus FruquintinibOral paclitaxel solution: 200mg/m2, p.o., bid, on days 1, 8, and 15 of each 28-day cycle. Fruquintinib: 4 mg orally once daily, 3 weeks on/1week off |
| Investigator-Selected Chemotherapy | Active comparator | Drug: Investigator Choice (IC) ChemotherapyInvestigator-selected chemotherapy includes injectable taxanes (paclitaxel injection, albumin-bound paclitaxel, docetaxel, etc.), irinotecan, etc., excluding oral paclitaxel solution. Regimens and doses shall be determined by the investigator in accordance with recommendations from current clinical guidelines. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 to 75 years, regardless of sex;
- Histologically and/or cytologically confirmed advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has failed first-line therapy or developed intolerable toxicity to first-line treatment.
- Presence of at least one measurable lesion per RECIST v1.1 criteria (Note: Previously irradiated lesions cannot be used as target lesions unless unequivocal progression of the lesion after radiotherapy is documented);
- Body weight ≥40 kg or BMI >18.5 kg/m²;
- No severe hematologic, hepatic, or renal abnormalities:
Key exclusion criteria (19 listed)
- Known HER2-positive status without prior anti-HER2 therapy (patients who progressed after anti-HER2 therapy are eligible);
- History of another primary malignancy within 3 years prior to the first study drug administration, except for adequately treated basal cell or squamous cell carcinoma of the skin, or in situ carcinomas of the cervix, breast, or other sites;
- Receipt of radiotherapy (except palliative radiotherapy), chemotherapy, or small-molecule targeted anticancer therapy within 4 weeks or within 5 half-lives of the agent (whichever is shorter) prior to the first dose of study drug. Patients who discontinued other investigational agents for more than 5 half-lives are eligible for screening. Additionally, treatment with large-molecule targeted anticancer agents within 4 weeks prior to the first study drug dose is prohibited;
- Toxicity from prior anticancer therapy not recovered to ≤ Grade 1 or baseline levels (except alopecia; neurotoxicity must have resolved to ≤ Grade 2) within 2 weeks prior to the first study drug administration;
- Presence of dysphagia, uncontrolled nausea, vomiting, diarrhea, or known malabsorption syndrome that may interfere with oral drug absorption;
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 |
|---|---|---|
| Oral Paclitaxel Solution Plus FruquintinibPatients received oral paclitaxel plus fruquintinib in 4-week cycles until disease progression, death, unacceptable toxicity, withdrawal of consent, iscontinuation by the investigator or study completion or termination. | Drug | Oral Paclitaxel Solution Plus Fruquintinib |
| Investigator Choice (IC) ChemotherapyInvestigator' choice of chemotherapy is given until disease progression, death, unacceptable toxicity, withdrawal of consent, iscontinuation by the investigator or study completion or termination. | Drug | Investigator-Selected Chemotherapy |
Primary outcome
Progression-free survival（PFS）
Time frame: assessed up to 1 year
Progression-free survival (PFS) is defined as the time from the date of randomization to disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.
5 secondary outcomes
Objective response rate（ORR）
Time frame: assessed up to 1 year
Disease Control Rate（DCR）
Time frame: assessed up to 1 year
Overall survival（OS）
Time frame: From randomization until death due to any cause, up to 3 years.
Adverse event
Time frame: From first dose to 30 days post the last dose
Qualtiy of life assesd by EORTC QLQ-C30 v3.0
Time frame: Evaluation from baseline to the 30 days post the last dose
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 28 Oct 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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Paclitaxel Solution Plus Fruquintinib and Investigator Choice (IC) Chemotherapy in people with Gastric Cancer or Gastroesophageal Junction Adenocarcinoma, run by Harbin Medical University at 15 sites 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 11 inclusion and 19 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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.
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 Yanqiao Zhang (86-138 4512 0210, yanqiaozhang@ems.hrbmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival（PFS） (time frame: 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 28 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.