Neoadjuvant TreatmentPhase 2NCT04620473
Anlotinib Hydrochloride Combined With Capeox in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer
A Phase 2 study testing Anlotinib+Capeox and Capeox in people with Neoadjuvant Treatment and Rectal Cancer, run by Shanghai Minimally Invasive Surgery Center.
Trial summary
Prospectively Investigate the effectiveness and safety of anlotinib hydrochloride combined with Capeox in neoadjuvant treatment of patients with locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neoadjuvant Treatment, Rectal Cancer, Anlotinib
- What is being tested?
- Anlotinib+Capeox and Capeox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Oct 2024
- Phase
- Phase 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
- Subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up;
- Male or female patients between the ages of 18-75;
- Patients diagnosed as rectal adenocarcinoma by histology or cytology;
- Stage: Locally advanced stage (T3-4N0M0 or T1-4N+M0);
- Evaluation of middle and low rectal cancer with the lower pole of the tumor less than 12 cm from the anal margin by MRI;
- Have not received other anti-angiogenic drugs or chemotherapy drugs in the past;
- ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points;
- Has sufficient organ and bone marrow function
Who cannot join
- Other malignant tumors that have appeared or are currently suffering from within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)];
- A distant transfer occurs;
- Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, etc.);
- Accompanied by pleural effusion or ascites, causing respiratory syndrome (NCI-CTC AE V5.0 grade ≥ 2 dyspnea);
- Patients with any severe and/or uncontrollable disease；
- Patients with gastrointestinal diseases with bleeding tendency (such as active gastrointestinal ulcers) or patients determined by the researcher to cause gastrointestinal bleeding, perforation or obstruction
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- Patients whose imaging shows that the tumor has invaded the tissues around important blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the follow-up study;
- Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before grouping;
- Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before grouping, patients with any bleeding or bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers Or fracture
- Those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
- People with a history of psychotropic drug abuse and unable to quit or have mental disorders;
- Participated in other anti-tumor drug clinical trials within four weeks;
- According to the judgment of the investigator, those with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study;
- Female patients who are pregnant or breastfeeding;
- Known hypersensitivity to any study drug.
About this study
Official title: Anlotinib Hydrochloride Combined With Capeox in the Neoadjuvant Treatment of Locally Advanced Rectal cancer-a Prospective, Open, Single Center and Randomized Controlled Phase Ⅱ Clinical Trial
Prospectively Investigate the effectiveness and safety of anlotinib hydrochloride combined with Capeox in neoadjuvant treatment of patients with locally advanced rectal cancer.
- Conditions
- Neoadjuvant Treatment, Rectal Cancer, Anlotinib
- Being tested
- Anlotinib+Capeox, Capeox
- Keywords
- Neoadjuvant Treatment, Rectal cancer, Anlotinib
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib+CapeoxDrug
to use Anlotinib hydrochloride combined with Capeox in the neoadjuvant treatment of locally advanced rectal cancer
CapeoxDrug
to use Capeox in the neoadjuvant treatment of locally advanced rectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib+Capeox | Experimental | neoadjuvant treatment with Anlotinib hydrochloride combined with Capeox Receives: Drug: Anlotinib+Capeox |
| Capeox | Active comparator | neoadjuvant treatment with Capeox Receives: Drug: Capeox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate（ORR）
Refers to the proportion of subjects whose tumors have shrunk to a certain amount and maintained for a certain period of time in the FAS concentration, including CR and PR cases
Measured: an average of three months
Secondary outcomes (6)
Pathological complete response rate
Refers to the pathological examination of primary tumors and lymph node surgical specimens without residual infiltrating tumor cells (ypT0N0)
Measured: one month after surgery
R0 resection rate
Refers to the surgically removed tissue without residual cancer cells
Measured: one month after surgery
Local disease recurrence time
Refers to the tumor reappearing at or near the same site as the primary cancer. The starting time is the first day after surgery.
Measured: 3 years after surgery
Overall survive
Refers to the time from the start of randomization to death due to any cause. The starting time is the first day after surgery.
Measured: 3 years after surgery
Disease-free survival rate
It refers to the time from the beginning of randomization to the incurable resection, local recurrence or metastasis, or death from any cause. The starting time is the first day after surgery.
Measured: 3 years after surgery
Postoperative complications
Postoperative complications
Measured: one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Nov 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Oct 2024 (estimated)
Why it stopped: No approval from ethical committee
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant TreatmentStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cai Zhenghao, Shanghai Minimally Invasive Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620473
- Sponsor's protocol ID
- MISC-Anlotinib+Capeox
- Status last verified
- Sep 2021
- First submitted
- 29 Oct 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anlotinib Hydrochloride Combined With Capeox in the Neoadjuvant Treatment of Locally Advanced Rectal cancer-a Prospective, Open, Single Center and Randomized Controlled Phase Ⅱ Clinical Trial
- ClinicalTrials.gov ID
- NCT04620473
- Acronym / sponsor ID
- MISC-Anlotinib+Capeox
- Conditions
- Neoadjuvant Treatment, Rectal Cancer, Anlotinib
- Keywords
- Neoadjuvant Treatment, Rectal cancer, Anlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No approval from ethical committee
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 9 Nov 2020 (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.
Prospectively Investigate the effectiveness and safety of anlotinib hydrochloride combined with Capeox in neoadjuvant treatment of patients with locally advanced rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib+Capeox | Experimental | Drug: Anlotinib+Capeoxneoadjuvant treatment with Anlotinib hydrochloride combined with Capeox |
| Capeox | Active comparator | Drug: Capeoxneoadjuvant treatment with Capeox |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up;
- Male or female patients between the ages of 18-75;
- Patients diagnosed as rectal adenocarcinoma by histology or cytology;
- Stage: Locally advanced stage (T3-4N0M0 or T1-4N+M0);
- Evaluation of middle and low rectal cancer with the lower pole of the tumor less than 12 cm from the anal margin by MRI;
Key exclusion criteria (15 listed)
- Other malignant tumors that have appeared or are currently suffering from within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)];
- A distant transfer occurs;
- Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, etc.);
- Accompanied by pleural effusion or ascites, causing respiratory syndrome (NCI-CTC AE V5.0 grade ≥ 2 dyspnea);
- Patients with any severe and/or uncontrollable disease；
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 |
|---|---|---|
| Anlotinib+Capeoxto use Anlotinib hydrochloride combined with Capeox in the neoadjuvant treatment of locally advanced rectal cancer | Drug | Anlotinib+Capeox |
| Capeoxto use Capeox in the neoadjuvant treatment of locally advanced rectal cancer | Drug | Capeox |
Primary outcome
Objective Response Rate（ORR）
Time frame: an average of three months
Refers to the proportion of subjects whose tumors have shrunk to a certain amount and maintained for a certain period of time in the FAS concentration, including CR and PR cases
6 secondary outcomes
Pathological complete response rate
Time frame: one month after surgery
R0 resection rate
Time frame: one month after surgery
Local disease recurrence time
Time frame: 3 years after surgery
Overall survive
Time frame: 3 years after surgery
Disease-free survival rate
Time frame: 3 years after surgery
Postoperative complications
Time frame: one month after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib+Capeox and Capeox in people with Neoadjuvant Treatment and Rectal Cancer, run by Shanghai Minimally Invasive Surgery Center.
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 8 inclusion and 15 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: withdrawn, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Objective Response Rate（ORR） (time frame: an average of three months). 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 Sep 2021.