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

Peking Union Medical College Hospital8 sites in 1 country32 target enrollmentNovember 5, 2021

ConditionsColorectal Cancer

InterventionsAnlotinib Penpulimab

DrugsAnlotinib Penpulimab

Overview

Phase: Phase 2
Intervention: Anlotinib
Conditions: Colorectal Cancer
Sponsor: Peking Union Medical College Hospital
Enrollment: 32
Locations: 8
Primary Endpoint: Progression-free survival (PFS)
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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)

Registry

clinicaltrials.gov

Start Date

November 5, 2021

End Date

August 23, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peking Union Medical College Hospital

Responsible Party

Principal Investigator

YueJuan Cheng

Prof.M.D.

Peking Union Medical College Hospital

Eligibility Criteria

Inclusion Criteria

•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.
•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
•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.

Exclusion Criteria

•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.
•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.

Arms & Interventions

Anlotinib+Penpulimab

Intervention: Anlotinib

Anlotinib+Penpulimab

Intervention: Penpulimab

Outcomes

Primary Outcomes

Progression-free survival (PFS)

Time Frame: up to 24 months

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.

Secondary Outcomes

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Until 30 day safety follow-up visit)
Objective Response Rate (ORR)(up to 24 months)
Disease Control Rate (DCR)(up to 24 months)
Duration of Response (DOR)(up to 24 months)
Overall Survival (OS)(Up to 24 months)