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Advanced Solid TumorPhase 1/2NCT03903705

: A Phase Ib/II Study To Evaluate Fruquintinib Monotherapy Or Plus Sintilimab In Advanced Solid Tumors

A Phase 1/2 study testing Fruquintinib in Combination with Sintilimab in people with Advanced Solid Tumor, run by Hutchmed at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a phase Ib/II study to evaluate the safety, tolerability, PK profile and preliminary efficacy of fruquintinib monotherapy or plus sintilimab for advanced solid tumors. This study includes fruquintinib plus sintilimab treatment arm (dose escalation phase and dose expansion phase), and fruquintinib monotherapy… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
Fruquintinib in Combination with Sintilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
348 participants
Where
1 siteChina
Study dates
25 Apr 2019to 16 Dec 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

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 fully understood and voluntarily sign the ICF for this study (the icf must be signed before any trial-specific procedures are performed);
  • Age of 18-75 years (inclusive); BMI ≥18.5 kg/m2;
  • Tumor types:
  • Fruquintinib plus sintilimab treatment arm
  • Dose escalation phase: patients with histologically or cytologically confirmed inoperable or metastatic advanced solid tumors (including but not limited to HCC, ovarian cancer, endometrial cancer, thymic cancer, NSCLC, renal cell carcinoma);
  • Dose expansion phase: histologically or cytologically confirmed inoperable metastatic advanced HCC (Barcelona Clinic Liver Cancer [BCLC] stage B or C), advanced renal cell carcinoma with clear cell component, advanced endometrial cancer, advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, advanced colorectal adenocarcinoma, advanced NSCLC, advanced cervical cancer, etc.;
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  • Fruquintinib monotherapy treatment arm: histologically or cytologically confirmed metastatic advanced endometrial cancer that cannot be surgically resected or treated with radical radiotherapy;
  • In the expansion phase, patients should agree to provide tissue specimens for detection of PD-L1 expression levels and/or MSI or dMMR status;
  • Requirement for prior systemic antitumor therapy:
  • Fruquintinib plus sintilimab treatment arm:
  • Dose escalation phase: patients who have failed standard treatment (PD or intolerable toxicity after treatment), have no available standard treatment or cannot receive standard treatment (such as economic limitations);
  • Dose expansion phase:
  • Part 1
  • Patients (HCC, renal cell carcinoma, endometrial cancer, gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, colorectal adenocarcinoma, cervical cancer, NSCLC) should have PD or intolerable toxicity after 1 standard treatment, or cannot receive standard treatment (such as economic limitations or patient's wishes, etc.). Among them, requirements of standard treatment are defined as follows:
  • Patients with HCC who have received 1 molecular targeted therapy (sorafenib or lenvatinib) or/and systemic chemotherapy (arsenious acid monotherapy or oxaliplatin-based combination therapy);
  • Patients with renal cell carcinoma who have received 1 standard systemic antitumor therapy (sunitinib, sorafenib, pazopanib, axitinib, cabozantinib, bevacizumab plus IFN-α, temsirolimus);
  • Patients with endometrial cancer who have received ≤2 line of platinum-based double drug systemic antitumor therapy (excluding hormonal therapy) and had PD or Grade ≥3 SAE, or had recurrence or PD after completion of at least 4 cycles of platinum-based double drug chemotherapy. Patients with recurrence or metastasis during or within 12 months after completion of neoadjuvant/adjuvant chemotherapy with platinum-based regimen are considered to have received first-line treatment (4 cycles are required for neoadjuvant/adjuvant chemotherapy, and if less than 4 cycles, it is also eligible to have PD or Grade ≥3 SAE during the treatment);
  • Patients with cervical cancers who have recurrent or metastasized squamous cell carcinoma, adenocarcinoma, or adeno-squamous carcinoma after at least one line of platinum-based chemotherapy (patients are considered to have received first-line treatment if they have recurrent or metastasized during or within 6 months after platinum-based neoadjuvant or adjuvant chemotherapy);
  • Patients with gastric adenocarcinoma and gastroesophageal junction adenocarcinoma who have failed prior standard chemotherapy and can provide tumor tissues for PD-L1 expression detection with CPS ≥1;
  • Patients with colorectal adenocarcinoma previously treated with fluoropyrimidine+leucovorin calcium+platinum or irinotecan+cetuximab/bevacizumab.
  • Advanced NSCLC (stage IV NSCLC diagnosed per AJCC 8th version):
  • Patients with negative driver gene (EGFR/ALK/ROS-1 negative) who have failed prior standard treatment or have intolerable toxicity, or cannot receive or are unwilling to receive current standard treatment, and with PD-L1 expression level TPS (tumor proportion score) ≥1% tested by central laboratory arranged by the sponsor.
  • Patients with NSCLC diagnosed with squamous cell carcinoma do not require test of EGFR mutation, ALK and ROS1 fusion per current diagnosis and treatment guidelines. Other non-squamous NSCLC patients can be included if they have a prior test report demonstrating no driver gene mutation/rearrangement (EGFR, ALK, ROS1); if there is no prior corresponding gene report, archived or fresh tissue needs to be collected for testing at the study site, or at the central laboratory arranged by sponsor.
  • Patients who have recurrence or metastasis during or within 6 months after prior neoadjuvant/adjuvant therapy are considered as having received first-line therapy.
  • Part 2
  • To enroll patients with renal cell carcinoma who have not received systemic therapy, the specific requirements are as follows:
  • Patients with renal cell carcinoma have not received any prior systemic antitumor therapy for renal cell carcinoma (patients with recurrence or PD >6 months after postoperative adjuvant chemotherapy can be enrolled), and patients with prior cytokine therapy are allowed.
  • Fruquintinib monotherapy arm: patients with histologically or cytologically confirmed advanced recurrent or metastatic endometrial cancer who cannot be surgically resected or treated with radical radiotherapy and have failed at least 1 standard treatment (including PD and intolerable toxicity).
  • ECOG performance status (ECOG PS) of 0 or 1;
  • Child-Pugh Class A (<7 points) for liver function, only applicable to patients with HCC;
  • Measurable tumor lesions per RECIST 1.1, where patients with gastric tumor are required to have measurable lesions outside of the stomach (in the dose escalation phase, patients with only the evaluable lesions are acceptable); if the lesion priorly treated with local therapy (radiotherapy, ablation, interventional therapy, etc.) is the only lesion, there must be definite imaging evidence of PD for that lesion;
  • Laboratory test results of bone marrow, liver and kidney function, and coagulation function within 7 days before the first dose should meet the following criteria (no blood transfusion, blood products, granulocyte colony-stimulating factor or other hematopoietic stimulating factor correction within 7 days before the laboratory test)
  • Absolute neutrophil count (ANC) ≥1.5×109/L and platelets ≥100×109/L (platelets ≥80×109/L in patients with HCC) and hemoglobin ≥90 g/L;
  • Serum total bilirubin (TBIL) ≤1.5 times upper limit of normal (×ULN);
  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤1.5×ULN without liver metastases; ALT and/or AST ≤3×ULN with liver metastases and HCC;
  • Serum albumin ≥28 g/L;
  • Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min (calculated per Cockcroft-Gault formula);
  • Protein urine < 2+; if protein urine ≥ 2+, 24-hour protein urine quantification should be <1 g;
  • International normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5×ULN (except for prophylactic use of anticoagulant drugs);
  • Life expectancy of ≥12 weeks;
  • Female of childbearing potential must have a negative blood pregnancy test within 7 days before the first dose. Male or female patients of childbearing potential should voluntarily use an effective contraceptive method during the study and within 6 months after the last dose of study drug, such as double-barrier contraceptive method, condom, oral or injectable contraceptives, intrauterine device, abstinence, etc. All female patients are considered to be of childbearing potential unless they are postmenopausal, have undergone artificial menopause, or are sterilized (hysterectomy, excision of both adnexa).

Who cannot join

  • The AEs related to prior antitumor therapy which do not recover to ≤ CTCAE Grade 1 before the first dose, except alopecia and peripheral neurotoxicity of CTCAE Grade ≤2 caused by platinum chemotherapy;
  • Patients with other malignant tumors (except cured cutaneous basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ) within 5 years before screening, only applicable to patients in expansion phase;
  • Histological diagnosed fibrolamellar HCC, sarcomatoid HCC or mixed components of the above pathological types; or gastric squamous cell carcinoma or gastric adenosquamous carcinoma; or carcinosarcoma or sarcoma (endometrial cancer); or pathological diagnosis MSI-H or dMMR (endometrial cancer)
  • Patients with previous or screening stage central nervous system (CNS) metastasis during screen period (for lung cancer patients with brain metastasis who have prior treatment, if there is no evidence of radiographic progression within ≥4 weeks before the first dose of study drug, and are clinically stable for ≥2 weeks after treatment, and have discontinued corticosteroids within 3 days before the first dose, the patient could be enrolled; for patients with untreated, asymptomatic lung cancer with brain metastasis [i.e., no neurological symptoms, no need for corticosteroid or antiepileptic treatment, no brain metastasis >1.5 cm in long diameter, no significant edema around brain metastasis], they could be enrolled);
  • Systemic antitumor therapy approved or under study within 4 weeks before the first dose, including but not limited to: chemotherapy (oral fluoropyrimidines washout period of 2 weeks), endocrine therapy, biological immunotherapy, targeted therapy (small molecule targeted therapy washout period of 2 weeks or 5 half-lives, whichever shorter), Traditional Chinese Medicine treatment (Traditional Chinese Medicine treatment with definite antitumor indications in the instructions, a 1-week washout period before the first dose is acceptable);
  • Radical radiotherapy (including more than 25% bone marrow radiotherapy) within 4 weeks before the first dose;
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  • Brachytherapy (such as implantation of radioactive particles) within 60 days before the first dose;
  • Patients previously treated with any anti-programmed cell death receptor 1 (PD-1) antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody (or any other antibody acting on T cell costimulation or checkpoint pathway) (only for the fruquintinib plus sintilimab treatment arm), or fruquintinib;
  • Corticosteroids (dose >10 mg/day prednisone or equivalent of other corticosteroids) or other immunosuppressive drugs for systemic treatment within 4 weeks before the first dose; nasal spray, inhalation or other topical use of corticosteroids (i.e., no more than 10 mg/day prednisone or equivalent of other glucocorticoids) are allowed;
  • Patients with any active autoimmune disease requiring systemic treatment (i.e., use of disease remission drugs, glucocorticoids or immunosuppressive drugs) within the past 2 years; patients who only need replacement therapy (thyroid, adrenal or pituitary dysfunction with thyroid, insulin or physiological glucocorticoid replacement therapy) can be enrolled;
  • Any live or attenuated live vaccines within 4 weeks before the first dose or planned administration during the study;
  • Major surgical operation within 60 days before the first dose;
  • Any surgery or invasive treatment within 4 weeks before the first dose (stable fistula formation required for fistulization for 4 weeks, except needle biopsy, venous fistula); or unhealed wounds, ulcers, fractures;
  • Uncontrolled malignant pleural effusion, ascites or pericardial effusion (defined as not effectively controlled by diuretics or paracentesis, as judged by the investigator);
  • Patients with hypertension uncontrolled by drugs, defined as: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;
  • Patients with any disease or condition that affects drug absorption, or the patient could not take the drug orally;
  • Strong cytochrome P450 (CYP) 3A4 inducer/inhibitor, p-glycoprotein (P-gp) substrate and breast cancer resistance protein (BCRP) substrate within 2 weeks or less than 5 half-lives (whichever is longer) before the first dose;
  • Patients with active gastric and duodenal ulcer, ulcerative colitis and other gastrointestinal diseases or unresected tumor with active bleeding, or other conditions that may cause gastrointestinal bleeding and perforation as judged by the investigator; or patients with prior gastrointestinal perforation or gastrointestinal fistula who had not recovered after surgical treatment;
  • Patients with evidence or history of bleeding tendency (such as melena, hematemesis, hemoptysis, bloody feces, etc.) within 2 months before the first dose, regardless of severity;
  • Tumor invading major vascular structures, such as pulmonary artery, superior/inferior vena cava, etc. found during screening, with greater risk of bleeding judged by the investigator;
  • Patients with a history of arterial thrombosis or deep venous thrombosis within 6 months before the first dose; or patients with stroke events and/or transient ischemic attack within 12 months; except that patients with thrombosis caused by implantable venous infusion pump or catheter, or patients with stable superficial venous thrombosis after conventional anticoagulant therapy;
  • Patients with clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina or coronary artery bypass grafting within 6 months before the first dose; congestive heart failure of New York Heart Association (NYHA) class ≥ 2; left ventricular ejection fraction (LVEF) of < 50%;
  • Patients with an active infection or unexplained fever (body temperature >38.5oC) during the screening period or before the first dose;
  • Patients with active pulmonary tuberculosis who are receiving anti-tuberculosis treatment or received anti-tuberculosis treatment within 1 year before the first dose;
  • Patients with prior and current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired pulmonary function and other conditions that may interfere with the detection and treatment of suspected drug-related pulmonary toxicity;
  • Known human immunodeficiency virus (HIV) infection;
  • Known history of clinically significant liver disease, including active viral hepatitis, (hepatitis B virus surface antigen [HBsAg] and/or hepatitis B virus core antibody [HbcAb] positive, hepatitis B virus [HBV] DNA >10000 copies/mL or > 2000 IU/mL; hepatitis C virus [HCV] antibody positive and HCV RNA positive), or other active hepatitis, clinically significant moderate to severe cirrhosis;
  • Other clinical drug treatment that has not been approved or marketed in China within 4 weeks before the first dose;
  • Women who are pregnant (positive pregnancy test before dose) or breastfeeding;
  • Known hypersensitivity to any component of the sintilimab, fruquintinib formulation, or prior history of severe allergy to any other monoclonal antibody;
  • Patient with any other condition or laboratory abnormalities that, in the opinion of the investigator, will increase the risk of study participation or interfere with the interpretation of study results, and is not suitable for the clinical study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 201203

Other trials in China

About this study

Official title: A Phase Ib/II Study To Evaluate The Safety, Tolerability, Pharmacokinetic Profile And Preliminary Efficacy Of Fruquintinib Monotherapy Or Plus Sintilimab In Advanced Solid Tumors

This is a phase Ib/II study to evaluate the safety, tolerability, PK profile and preliminary efficacy of fruquintinib monotherapy or plus sintilimab for advanced solid tumors. This study includes fruquintinib plus sintilimab treatment arm (dose escalation phase and dose expansion phase), and fruquintinib monotherapy arm.

Read the detailed description

This study is composed of Fruquintinib plus sintilimab treatment arm and Fruquintinib monotherapy arm.

Fruquintinib plus sintilimab treatment arm:

  • Dose escalation phase: it is planned to enroll about 26-39 patients
  • Dose expansion phase: it is planned to enroll about 309-329 patients, including about 140 patients with endometrial cancer

Fruquintinib monotherapy arm: about 13 patients with advanced endometrial cancer

Being tested
Fruquintinib in Combination with Sintilimab
Keywords
Fruquintinib, Sintilimab, VEGFR, PD-1, Solid Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fruquintinib in Combination with SintilimabDrug

    Also called Fruquintinib

    Fruquintinib plus Sintilimab:

    Cohort A: Fruquintinib 3 mg QD, oral dosing, 3 weeks on/1 weeks off +Sintilimab 200mg Q4W, intravenous dosing.

    Cohort B: Fruquintinib 4 mg QD, oral dosing, 3 weeks on/1 weeks off +Sintilimab 200mg Q4W, intravenous dosing

    Cohort C: Fruquintinib 5 mg QD, oral dosing, 2weeks on/1 weeks off + Sintilimab 200mg Q3W, intravenous dosing

    Cohort E: Fruquintinib 3 mg QD, continuous, oral dosing, + Sintilimab 200mg Q3W, intravenous dosing

    Fruquintinib monotherapy arm:

    Fruquintinib 5 mg QD, oral dosing, 3 weeks on/1 weeks off

    Patients will be treated until disease progression, death, unacceptable toxicity, loss of follow-up, withdrawal of consent or other conditions meet the end of treatment criteria.

Study groups in NCT03903705
Study groupRoleWhat they receive
VEGFR cohort:ExperimentalFruquintinib
Receives: Drug: Fruquintinib in Combination with Sintilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose escalation phase: Safety outcome evaluation - DLT, MTD/RP2D

    Dose escalation phase: To evaluate the safety and tolerability of fruquintinib plus sintilimab for advanced solid tumors in the dose escalation phase, to observe dose-limiting toxicity (DLT), the maximum tolerated dose (MTD) and/or to determine the recommended phase 2 dose (RP2D) and administration strategy of the combination therapy.

    Measured: From first dose to 30 days post the last dose

  2. Dose expansion phase (except EMC cohort): efficacy outcome evaluation - ORR based on the investigator's tumor assessment

    Dose expansion phase (except endometrial cancer [EMC] cohort): ORR assessed by investigator

    Measured: very 6 weeks since Cycle1 Day 1, and every 12 weeks after Week 48, until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent

  3. Dose expansion phase (EMC cohort): efficacy outcome evaluation - ORR based on IRC's tumor assessment

    Dose expansion phase (EMC cohort): ORR by IRC

    Measured: Every 6 weeks since Cycle1 Day 1, and every 12 weeks after Week 48, until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent

  4. Fruquintinib monotherapy arm: efficacy outcome evaluation - ORR based on investigator's tumor assessment

    Fruquintinib monotherapy arm: ORR by investigator

    Measured: Every 6 weeks since Cycle1 Day 1, and every 12 weeks after Week 48, until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent

Secondary outcomes (7)

  1. Immunogenicity Assessments for Anti-drug Antibody(ADA)

    Immunogenicity Assessments for Anti-drug Antibody(ADA)

    Measured: From Cycle 1, 2, 4, 6, 8, 12 (each cycle is 28 days) and the safety visit for Sintilimab until disease progression or death or new anti-cancer therapy or withdrawal of consent

  2. pharmacokinetics (PK) Assessments

    To evaluate the PK profile of fruquintinib plus sintilimab

    Measured: From Cycle 1 for Fruquintinib; Cycle 1, 2, 3, 4 for Sintilimab in the dose escalation phase, and Cycle 1, 2, 4, 12 for dose expansion phase.

  3. Dose expansion phase (except EMC cohort): Efficacy outcome evaluation - DCR, PFS, OS, DoR, TTR based on the investigator's tumor assessment

    Dose expansion phase (except EMC cohort): DCR, PFS, OS, DoR, TTR by investigator

    Measured: Every 6 weeks since Cycle1 Day 1, and every 12 weeks after Week 48, until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent

  4. Dose expansion phase (EMC cohort): Efficacy outcome evaluation - ORR, DCR, PFS, OS, DoR, TTR based on the investigator's tumor assessment

    Dose expansion phase (EMC cohort): ORR, DCR, PFS, OS, DoR, TTR by investigator

    Measured: Every 6 weeks since Cycle1 Day 1, and every 12 weeks after Week 48, until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent

  5. Dose expansion phase (EMC cohort): Efficacy outcome evaluation - DCR, PFS, OS, DoR, TTR based on the IRC's tumor assessment

    Dose expansion phase (EMC cohort): DCR, PFS, OS, DoR, TTR by IRC

    Measured: Every 6 weeks since Cycle1 Day 1, and every 12 weeks after Week 48, until disease progression or death or new anti-cancer therapy or loss of follow-up or withdrawal of consent

  6. Safety outcome evaluation

    Overall incidence of AEs, incidence of Grade ≥ 3 AEs, etc.

    Measured: From first dose to 30 days post the last dose

  7. Biomarker evaluation

    Detect the expression of PD-L1 and/or other biomarkers in tumor tissues of patients, and analyze the relevant efficacy to provide reference for determining the dominant population.

    Measured: From first dose to 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.

  1. First posted4 Apr 2019
  2. Study start25 Apr 2019
  3. Primary completion15 Nov 2023
  4. Study completion16 Dec 2024

Resources

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
Sequential
Model description
Open-Label Phase 1b/II Study of Fruquintinib in Combination with Sintilimab to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced Solid Tumor.
Masking
None (open label)
Enrolment
348 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03903705
Sponsor's protocol ID
2018-013-00CH3
Status last verified
Apr 2025
First submitted
27 Mar 2019
Last updated
6 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wu X, Wang J, Wang D, Li G, Zhang J, Chen H, Yang H, Zhou Q, Wang K, Wu Y, Yi T, Liu J, Huang Y, Bai Y, Wang K, Jiang K, Lou H, An R, Li X, Pan Y, Wang Y, Tao W, Song K, Kang Y, Li Y, Shi W, Liu A, Yang Y, Wang Y, Chen K, Shi H, Lu P, Tan P, Fan S, Shi M, Su W. Fruquintinib plus sintilimab in patients with advanced endometrial cancer with mismatch-repair proficient status: a multicenter, single-arm, phase Ib/II trial. Nat Commun. 2025 Dec 21;17(1):658. doi: 10.1038/s41467-025-67375-3.

    PubMed 41423492

  • Xu H, Yao X, He Z, Luo H, Li G, Guo J, Diao L, Fan Y, Li Y, Fan J, Hu X, Lu P, Shi H, Chen K, Tan P, Fan S, Shi M, Su W, Ye D. Fruquintinib Plus Sintilimab in Patients with Treatment-Naive and Previously Treated Advanced Renal Cell Carcinoma: Results from a Phase Ib/II Clinical Trial. Target Oncol. 2025 Jan;20(1):113-125. doi: 10.1007/s11523-024-01120-6. Epub 2025 Jan 13.

    PubMed 39806128

  • Guo Y, Zhang W, Ying J, Zhang Y, Pan Y, Qiu W, Fan Q, Xu Q, Ma Y, Wang G, Guo J, Su W, Fan S, Tan P, Wang Y, Luo Y, Zhou H, Li J. Phase 1b/2 trial of fruquintinib plus sintilimab in treating advanced solid tumours: The dose-escalation and metastatic colorectal cancer cohort in the dose-expansion phases. Eur J Cancer. 2023 Mar;181:26-37. doi: 10.1016/j.ejca.2022.12.004. Epub 2022 Dec 13.

    PubMed 36628898

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Fruquintinib in Combination with Sintilimab in people with Advanced Solid Tumor, run by Hutchmed 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 41 inclusion and 31 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: finished, as of the sponsor's last update on 6 Apr 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose escalation phase: Safety outcome evaluation - DLT, MTD/RP2D (time frame: From first dose to 30 days post the last dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03903705, which also lists 3 linked publications.

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 6 Apr 2025.

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