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Colorectal CancerPhase 2ALTER-C003NCT04970914

Anlotinib Plus Penpulimab (AK105) for Chemo-refractory Metastatic Colorectal Cancer:ALTER-C003

A Phase 2 study testing Anlotinib and Penpulimab in people with Colorectal Cancer, run by Peking Union Medical College Hospital at 8 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A single-arm, open-label clinical trial, focus on the safety and efficacy of anlotinib hydrochloride in combination with Penpulimab (AK105) in patients with Chemo-refractory Metastatic Colorectal Cancer (mCRC) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Anlotinib and Penpulimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
8 sitesChina
Study dates
5 Nov 2021to 23 Aug 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients participate in the study voluntarily and sign informed consent with good compliance.
  • Be 18 years of age or older on day of signing informed consent.
  • Histological or cytological confirmation of Metastatic Colorectal Cancer(T1-4N0-2M1).
  • At least one measurable lesion, with diameter ≥ 10mm measured by spiral MRI/CT scan per RECIST1.1.
  • Participants must have received and progressed through or become intolerant to fluoropyrimidine, irinotecan, oxaliplatin, Exceptions may apply.
  • Eastern Cooperative Oncology Group Performance Status 0 or 1.
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  • Life expectancy of at least 3 months.
  • Main organs function is normal. (normal main organs function as defined below: Hemoglobin (Hb) ≥ 90 g/L, Neutrophils (ANC) ≥ 1.5×109/L, leucocyte (WBC) ≥ 3.0×109/L,Platelet count (PLT) ≥ 75×109/L,Total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 ×ULN, If liver metastasis is present，ALT and AST<5ULN ；Serum creatinine (Cr) ≤ 1.5× ULN or Creatinine Clearance rate(CCr) ≥60ml/min，Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) > 50%)
  • The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 3 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 8 weeks after it.

Who cannot join

  • Histological or cytological confirmation of mucinous adenocarcinoma or ovarian transcoelomic metastasis
  • Patients who had previously received treatment with Anlotinib or anti-programmed cell death protein 1 (PD-1), programmed cell death protein 1 ligand 1 (PD-L1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors other immunotherapy against .
  • Patients who had previously received treatment within 2 weeks or Participated in other anti-tumor clinical trials within 4 weeks.
  • Patients with a large amount of pleural effusion or ascites requiring drainage.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
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  • Patients who underwent major surgery within 4 weeks.
  • Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 3 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, ulcers.
  • Patients with a risk of gastrointestinal bleeding may not be enrolled.
  • Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism.
  • Patients with any severe and/or unable to control diseases，including： Patients with unsatisfactory blood pressure control using antihypertensive drugs (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100) mmHg); Patients with Grade 2 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including male QTc≥450ms; female QTc≥470ms) and patients with Grade 2 or higher congestive heart failure (NYHA Classification); Patients with active or unable to control serious infections, which is over level 2 in CTC AE (4.0); Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L); Patients with kidney failure who require hemodialysis or peritoneal dialysis; Patients with interstitial lung disease with symptoms or signs of activity；Patients with a history of immunodeficiency, including a positive HIV test or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; Urine routine indicates that urine protein ≥ ++, and confirmed 24-hour urine protein quantitation > 1.0 g; Patients with any of the following coagulation functions are abnormal, including: Prothrombin time (PT)>ULN+4s, Activated partial thromboplastin time (APTT) >1.5ULN s, international normalized ratio (INR)>1.5; Patients with a seizure disorder who require pharmacotherapy.
  • Patients who have got non remissive toxic reactions derived from any treatment, which is over level 1 in CTC AE (4.0).
  • Has a diagnosis of immunodeficiency or is receiving chronic steroid therapy of prednisone ≥ 10 mg daily or any equivalent dose of corticosteroids.
  • Has received a live vaccine or attenuated vaccine within 30 days prior to trial registration.
  • Symptoms that affect oral medication and cannot be controlled through proper treatment (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.).
  • Female patients who are pregnant or breastfeeding.
  • Patients with drug abuse history and unable to get rid of or patients with mental disorders.
  • Patients who had serious adverse effect to Anlotinib or Penpulimab or any of its excipients
  • Known hypersensitivity to other Monoclonal Antibody or any of its excipients.
  • Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment.

Trial locations and contacts

8 sites in 1 country.

Jianfeng Zhou contact

011-86-10-69156114

ZhouJF@pumch.cn

8 sites in 1 country

China8 sites, 8 recruiting

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Xiaoyuan Li

    Xiaoyuan Li

    Recruiting

  • China-Japan friendship hospital

    Beijing, Beijing Municipality

    Yuan Li

    Yuan Li

    Not yet recruiting

  • Peking Union Medical College Hospital

    Beijing

    jianfeng Zhou, ZhouJF@pumch.cn

    Recruiting

  • Hebei Petro China Central Hospital

    Langfang, Hebei

    Qian Guo

    Qian Guo

    Not yet recruiting

  • The First Hospital Of China Medical University

    Shenyang

    Xiujuan Qu

    Not yet recruiting

  • The People's Hospital Of Liaoning Province

    Shenyang

    Du Zhenguang

    Not yet recruiting

  • The Fourth Hospital of Hebei Medical University (Hebei Cancer Hospital)

    Shijiazhuang, Hebei

    Ruixing Zhang, 0086-311-86095757

    Ruixing Zhang

    Not yet recruiting

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality

    Diansheng Zhong

    Diansheng Zhong

    Recruiting

Other trials in China

About this study

Official title: Anlotinib Hydrochloride In Combination With Penpulimab (AK105) in Patients With Chemo-refractory Metastatic Colorectal Cancer, Open, Single Arm,Exploratory Clinical Trial(ALTER-C003)

A single-arm, open-label clinical trial, focus on the safety and efficacy of anlotinib hydrochloride in combination with Penpulimab (AK105) in patients with Chemo-refractory Metastatic Colorectal Cancer (mCRC)

Being tested
Anlotinib, Penpulimab
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • AnlotinibDrug

    Also called anlotinib hydrochloride

    12mg, continuous oral 2 weeks stop for 1 week, 21 days for a treatment cycle.

  • PenpulimabDrug

    Also called AK105

    Penpulimab 200 mg administered intravenously every 3 weeks.

Study groups in NCT04970914
Study groupRoleWhat they receive
Anlotinib+PenpulimabExperimentalNot described
Receives: Drug: Anlotinib; Drug: Penpulimab

What is being measured

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

  1. Progression-free survival (PFS)

    Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: up to 24 months

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    Objective response rate is defined as the percentage of subjects whose best response was complete response (CR) or partial response (PR) according to the RECIST v1.1

    Measured: up to 24 months

  2. Disease Control Rate (DCR)

    Disease control rate is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the RECIST v1.1.

    Measured: up to 24 months

  3. Duration of Response (DOR)

    Duration of Response is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the RECIST v1.1 or death due to any cause, whichever occurs first.

    Measured: up to 24 months

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Adverse events assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).

    Measured: Until 30 day safety follow-up visit

  5. Overall Survival (OS)

    Overall Survival (OS) (median) is determined using the number of months measured from the initial date of treatment to the recorded date of death of participants.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2021
  2. Study start5 Nov 2021
  3. Primary completion23 Aug 2022 (estimated)
  4. Study completion23 Aug 2023 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04970914
Sponsor's protocol ID
HS-2986B
Acronym
ALTER-C003
Status last verified
Mar 2022
First submitted
5 Jul 2021
Last updated
8 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib and Penpulimab in people with Colorectal Cancer, run by Peking Union Medical College Hospital at 8 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 9 inclusion and 20 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 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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.

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?

Results are not available in the source record.

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

Contact Jianfeng Zhou (011-86-10-69156114, ZhouJF@pumch.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: up to 24 months). 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 NCT04970914.

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 8 Mar 2022.

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