Phase II Study to Evaluate the Efficacy and Safety of Fruquintinib Plus Sintilimab as Third-line Therapy for Colorectal Cancer

NCT04179084 | Unknown Phase 2

• 1 other identifier: Fruquintinib
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single center, investigator initiated phase II clinical study to evaluate the efficacy and safety of fruquintinib plus Sintilimab as third-line therapy for colorectal cancer

Conditions

Metastasis Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR).

  1year

Secondary Outcomes (2)

• Overall Survival (OS)

  1year

• Progression-free survival (PFS)

  1year

Study Arms (1)

fruquintinib + Sintilimab

EXPERIMENTAL

Drug: fruquintinib; Drug: Sintilimab

Interventions

fruquintinib DRUG

5mg qd, 2weeks on, 1week off

fruquintinib + Sintilimab

Sintilimab DRUG

200mg q3w

fruquintinib + Sintilimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
• Subjects with metastatic colorectal cancer(CRC) (Stage IV). Subjects must have failed at least two lines of prior treatment. Progression during or within 3 months following the last administration of approved standard therapies which must include a fluoropyrimidine, oxaliplatin and irinotecan.
• Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy.
• Subjects who progress more than 6 months after completion of oxaliplatin containing adjuvant treatment must be retreated with oxaliplatin-based therapy to be eligible.
• Subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study.
• Subjects may have received prior treatment with Avastin (bevacizumab) and/or Erbitux (cetuximab)/Vectibix (panitumumab) (if KRAS WT) Metastatic CRC subjects must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 1. Life expectancy of at least 12 weeks. Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.

You may not qualify if:

• \- Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-lymphocyte-associated Protein 4, CTLA-4) antibody or other drug/antibody that acts on T cell costimulation or checkpoint pathways.
• Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)\].
• Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization.
• Cardiological disease including Congestive heart failure, Unstable angina, Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.
• Uncontrolled hypertension. (Systolic blood pressure 150 mmHg or diastolic pressure 90 mmHg despite optimal medical management).
• Pleural effusion or ascites that causes respiratory compromise. Arterial or venous thrombotic or embolic events. Any history of or currently known brain metastases. Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
• Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 week.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

China PLAGH

Beijing, China

RECRUITING

MeSH Terms

Interventions

HMPL-013; sintilimab

Central Study Contacts

Guanghai Dai, M.D.

CONTACT

13801232381; daigh301@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 26, 2019
• Study Start: August 28, 2019
• Primary Completion: March 1, 2020
• Study Completion: May 1, 2020
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)