Advanced Solid TumorPhase 2/3NCT03975036
Clinical Study on the Second-line and Above Treatment of Advanced Solid Tumor With Anlotinib Combined With Pd-1 Antibody
A Phase 2/3 study testing Anlotinib and pd-1 antibody in people with Advanced Solid Tumor, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The main objective was to evaluate the safety and efficacy of anlotinib hydrochloride combined with pd-1 antibody second-line and above in the treatment of advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Anlotinib and pd-1 antibody
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2019to 8 Jul 2021
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed the informed consent form prior to patient entry.
- There is at least one measurable lesion in the pathologically diagnosed advanced solid tumor, including non-small cell lung cancer, liver cancer, gastric cancer, colorectal cancer, pancreatic cancer, soft tissue sarcoma, malignant melanoma, gallbladder cancer, esophageal cancer, ovarian cancer, endometrial cancer and breast cancer
- ≥ 18 and ≤ 70 years of age.
- Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
- Life expectancy of more than 3 months.
- Adequate hepatic, renal, heart, and hematologic functions: ANC ≥ 1.5×109/L, PLT ≥ 100×109/L, HB ≥ 90 g/L, TBIL ≤ 1.5×ULN, ALT or AST ≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1.5×ULN, Cr clearance ≥ 60 mL/min;Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%).
- Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 6 months after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 6 months after last dose of study drug.
Who cannot join
- uncontrollable hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal medical therapy), grade II The above myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc interval male ≥ 450 ms, female ≥ 470 ms).
- Patients previously treated with anticancer therapies also have a Toxicity Level> 1 in NCI CTCAE.
- A variety of factors that affect oral absorption (such as inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.).
- Patients with gastrointestinal bleeding risk may not be included, including the following: (1) active peptic ulcer lesions and fecal occult blood (++); (2) history of melena and vomiting within 3 months; (3) ) For fecal occult blood (+) must be gastroscopy, clear whether the existence of gastrointestinal organic diseases.
- Coagulation dysfunction (INR> 1.5, PT> ULN + 4s or APTT> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment.
- Long-term, unhealed wounds or fractures.
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- Active bleeding, within 30 days after major surgery.
- Intracranial metastasis.
- Pregnant or lactating women.
- Cytotoxic drug treatment, radiotherapy within 3 weeks after treatment; had taken two or more targeted drugs, or into the group before the other three months have been taking other targeted drugs.
- Other malignant tumors in the past 3 years.
- The investigators believe there is any condition that may harm the subject or result in the subject's inability to meet or perform the research requirements.
- Huge metastasis / recurrence (tumor diameter> 5 cm)。
- Malignant pleural effusion or ascites, causing NCI CTCAE grading 2 or more people with dyspnea.
- Any allergy to apatinib should be excluded.
- Severe liver and kidney dysfunction (grade 4) patients should be excluded.
- Persons with a history of substance abuse who can not be abdicated or have mental disorders.
- According to the judgment of the researcher, there is a concomitant disease that seriously endangers the patient's safety or affects the patient in completing the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Zibing Wang
About this study
Official title: Exploratory Clinical Study on the Second-line and Above Treatment of Advanced Solid Tumor With Anlotinib Hydrochloride Combined With Pd-1 Antibody: An Open-Label, Single-center, Single-arm Study
The main objective was to evaluate the safety and efficacy of anlotinib hydrochloride combined with pd-1 antibody second-line and above in the treatment of advanced solid tumors
Read the detailed description
To observe the beneficial population and adverse reactions of anlotinib hydrochloride combined with pd-1 in the treatment of patients with advanced solid tumor, and to explore the safe and effective drug treatment dose in the combined program, so that more patients with advanced tumor with poor prognosis can benefit from the combined program
- Conditions
- Advanced Solid Tumor
- Being tested
- Anlotinib, pd-1 antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
Also called Fu ke wei
Anlotinib Hydrochloride Capsules
pd-1 antibodyDrug
Also called Keytruda
Pembrolizumabinjection
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib&pd-1 antibody | Experimental | Anlotinib 10mg/d,q.d.,p.o.\&pd-1 antibody 200mg/d.q.3w.d.l.v Receives: Drug: Anlotinib; Drug: pd-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
From date of randomization until the date of first documented progression or date of death from any cause
Measured: up to 2 year
Secondary outcomes (3)
Objective Response Rate (ORR)
From date of randomization until the date of death from any cause
Measured: up to 1 year
Disease Control Rate (DCR)
Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
Measured: up to 1 year
Overall survival(OS)
From date of randomization until the date of death from any cause
Measured: up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start8 Apr 2019
- Primary completion8 Jun 2020 (estimated)
- Study completion8 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- Cttq
- Responsible party
- Sponsor
- Investigators
- Zibing Wang, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975036
- Sponsor's protocol ID
- 2019093
- Status last verified
- Jan 2019
- First submitted
- 23 May 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study on the Second-line and Above Treatment of Advanced Solid Tumor With Anlotinib Hydrochloride Combined With Pd-1 Antibody: An Open-Label, Single-center, Single-arm Study
- ClinicalTrials.gov ID
- NCT03975036
- Acronym / sponsor ID
- 2019093
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- Cttq
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 8 Jun 2020 (estimated)
- Study completion
- 8 Jul 2021 (estimated)
- First posted
- 5 Jun 2019 (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 main objective was to evaluate the safety and efficacy of anlotinib hydrochloride combined with pd-1 antibody second-line and above in the treatment of advanced solid tumors
Detailed description
To observe the beneficial population and adverse reactions of anlotinib hydrochloride combined with pd-1 in the treatment of patients with advanced solid tumor, and to explore the safe and effective drug treatment dose in the combined program, so that more patients with advanced tumor with poor prognosis can benefit from the combined program
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib&pd-1 antibody | Experimental | Drug: Anlotinib, Drug: pd-1 antibodyAnlotinib 10mg/d,q.d.,p.o.\&pd-1 antibody 200mg/d.q.3w.d.l.v |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed the informed consent form prior to patient entry.
- There is at least one measurable lesion in the pathologically diagnosed advanced solid tumor, including non-small cell lung cancer, liver cancer, gastric cancer, colorectal cancer, pancreatic cancer, soft tissue sarcoma, malignant melanoma, gallbladder cancer, esophageal cancer, ovarian cancer, endometrial cancer and breast cancer
- ≥ 18 and ≤ 70 years of age.
- Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
- Life expectancy of more than 3 months.
Key exclusion criteria (18 listed)
- uncontrollable hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal medical therapy), grade II The above myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc interval male ≥ 450 ms, female ≥ 470 ms).
- Patients previously treated with anticancer therapies also have a Toxicity Level> 1 in NCI CTCAE.
- A variety of factors that affect oral absorption (such as inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.).
- Patients with gastrointestinal bleeding risk may not be included, including the following: (1) active peptic ulcer lesions and fecal occult blood (++); (2) history of melena and vomiting within 3 months; (3) ) For fecal occult blood (+) must be gastroscopy, clear whether the existence of gastrointestinal organic diseases.
- Coagulation dysfunction (INR> 1.5, PT> ULN + 4s or APTT> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment.
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 |
|---|---|---|
| AnlotinibAlso: Fu ke weiAnlotinib Hydrochloride Capsules | Drug | Anlotinib&pd-1 antibody |
| pd-1 antibodyAlso: KeytrudaPembrolizumabinjection | Drug | Anlotinib&pd-1 antibody |
Primary outcome
Progression-free Survival (PFS)
Time frame: up to 2 year
From date of randomization until the date of first documented progression or date of death from any cause
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: up to 1 year
Disease Control Rate (DCR)
Time frame: up to 1 year
Overall survival(OS)
Time frame: up to 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
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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. This study is not recruiting at the moment.
Zibing Wang principal investigator
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Anlotinib and pd-1 antibody in people with Advanced Solid Tumor, run by Henan Cancer Hospital 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 7 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 5 Jun 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zibing Wang (18937621301, bingziwang@hotmail.com), 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: up to 2 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 Jun 2019.