Colorectal NeoplasmPhase 2NCT04866862
Fruquitinib Combined With Camrelizumab in Non MSI-H/dMMR Refractory Colorectal Cancer
A Phase 2 study testing Combination of Fruquintinib and Camrelizumab in people with Colorectal Neoplasm, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Limited agents are optional after standard first and second line treatment for mCRC. Nowadays, cancer therapy has entered the era of immunotherapy. The approved cancer therapies include pembrolizumab and nivolumab, but only for MSI-H patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Neoplasm
- What is being tested?
- Combination of Fruquintinib and Camrelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2021to 1 Jun 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
- Subjects with non MSI-H / dMMR metastatic colorectal cancer(CRC) (Stage IV)
- Subjects must have failed at least two lines of prior treatment, which must include a fluoropyrimidine, oxaliplatin and irinotecan.
- Subjects must not have been treated with Fruquitinib or any anti-PD-1 inhibitors.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.is necessary.
- Adequate bone marrow, liver, cardiac and renal function as assessed by the laboratory required by protocol.
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- Assigned informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Life expectancy of at least 3 months.
- Subjects must complete the treatment and follow-up on schedule according to the research plan.
- No brain metastasis, no spinal cord compression.
- Subjects agree to use blood samples for study analysis.
- Women of childbearing age must be negative in pregnancy test and willing to take effective contraceptive measures during the study period.
Who cannot join
- Subjects are severe malnutrition or need tube feeding.
- Radiotherapy or surgery has been performed within 30 days before treatment.
- Previous treatment with anti-PD-1 / PD-L1 inhibitor and / or fruquitinib.
- Other malignant tumors within 2 years and without cure (except for cured basal cell carcinoma of skin and carcinoma in situ of cervix);
- Subjects have active autoimmune system diseases、systemic hormone therapy or anti autoimmune drug therapy.
- Subjects with immunodeficiency or receiving systemic steroid therapy (prednisone > 10 mg / day or other equivalent drugs) or other forms of immunosuppressive therapy 7 days before the first dose of combination therapy in this study;
Show all 16Show fewer
- Subjects with active infection and still need systemic treatment 7 days before the first dose of therapy in this study.
- Subjects with uncontrollable systemic diabetes.
- Subjects with interstitial lung disease, non infectious pneumonia or pulmonary fibrosis;
- Subjects who have received allogeneic organ or stem cell transplantation in the past.
- Subjects allergic to the drugs or related components involved in this study.
- Are participating in other interventional clinical studies.
- The previous anti-tumor related adverses do not return to grade 1 in CTCAE before the first combination therapy.
- Subjects who have uncontrolled hypertension by drugs, that is, systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg.
- Thrombotic or hemorrhagic tendency or history within 60 days before the first medication, regardless of the severity.
- Any serious or unstable medical condition、mental illness or known active alcohol or drug abuse or dependence.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Yanhong Gu, PHD, 13813908678, guluer@163.com
About this study
Official title: A Single Arm, Open Label, Phase II, Exploratory Study of Fruquitinib Combined With Camrelizumab in Non MSI-H / dMMR Refractory Colorectal Cancer.
Limited agents are optional after standard first and second line treatment for mCRC. Nowadays, cancer therapy has entered the era of immunotherapy. The approved cancer therapies include pembrolizumab and nivolumab, but only for MSI-H patients. 95% of non MSI-H / dMMR patients with advanced colorectal cancer can not benefit from them. Therefore, the use of PD-1 / PD-L1 monoclonal antibody in mCRC is greatly limited. Our previous research showed that anti-PD-1 combined with Fruquintinib can significantly inhibit the growth of CRC in MSS mice. At the same time, a retrospective clinical study showed that patients with MSS CRC can benefit from Sintilimab combined with Fruquintinib. Camrelizumab is PD-1 monoclonal antibody, which has been approved for a variety of tumors. The prospective clinical trial of Camrelizumab combined with Fruquintinib may bring new hope for the treatment of non MSI-H / dMMR patients with mCRC.This study is aimed to explore the efficacy, safety in advanced colorectal cancer failed to standard therapy in Chinese population.
Read the detailed description
Our previous research showed that anti-PD-1 combined with Fruquintinib can significantly inhibit the growth of CRC in MSS mice. At the same time, a retrospective clinical study showed that patients with MSS CRC can benefit from Sintilimab combined with Fruquintinib. Camrelizumab is PD-1 monoclonal antibody, which has been approved for a variety of tumors. The prospective clinical trial of Camrelizumab combined with Fruquintinib may bring new hope for the treatment of non MSI-H / dMMR patients with mCRC.This study is aimed to explore the efficacy, safety in advanced colorectal cancer failed to standard therapy in Chinese population.
- Conditions
- Colorectal Neoplasm
- Being tested
- Combination of Fruquintinib and Camrelizumab
- Keywords
- colorectal cancer, non MSI-H/dMMR, Camrelizumab, Fruquintinib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Fruquintinib and CamrelizumabDrug
Also called Fruquintinib 5mg d1-21+Camrelizumab 200 mg d1
Fruquintinib 5mg d1-21+Camrelizumab 200 mg d1
| Study group | Role | What they receive |
|---|---|---|
| Combination of Fruquintinib and Camrelizumab | Experimental | Fruquintinib 5mg d1-21+ Camrelizumab 200mg d1; Repeated every 4 weeks Receives: Drug: Combination of Fruquintinib and Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate(ORR)
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)
Measured: up to 2 years
Secondary outcomes (4)
Progression-free Survival(PFS)
PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.
Measured: From date of subjects until the date of first documented progression or death from any cause, whichever came first, assessed up to 24 months
Overall Survival (OS)
OS is defined as the time from date of assignment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Measured: From assignment of the first subject until 32 death events observed, up to 2 years.
Disease control rate (DCR)
DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD)
Measured: up to 2 years
Tumor Mutation Burden (TMB)
The total number of somatic gene coding error, base substitution. gene insertions or deletions in every million base detected.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start26 Apr 2021
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rui Wang, Study chair, the first affilated hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866862
- Sponsor's protocol ID
- KEEP-G 05
- Status last verified
- Jul 2022
- First submitted
- 28 Mar 2021
- Last updated
- 25 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jacquelot N, Yamazaki T, Roberti MP, Duong CPM, Andrews MC, Verlingue L, Ferrere G, Becharef S, Vetizou M, Daillere R, Messaoudene M, Enot DP, Stoll G, Ugel S, Marigo I, Foong Ngiow S, Marabelle A, Prevost-Blondel A, Gaudreau PO, Gopalakrishnan V, Eggermont AM, Opolon P, Klein C, Madonna G, Ascierto PA, Sucker A, Schadendorf D, Smyth MJ, Soria JC, Kroemer G, Bronte V, Wargo J, Zitvogel L. Sustained Type I interferon signaling as a mechanism of resistance to PD-1 blockade. Cell Res. 2019 Oct;29(10):846-861. doi: 10.1038/s41422-019-0224-x. Epub 2019 Sep 3.
PubMed 31481761Brahmer JR, Drake CG, Wollner I, Powderly JD, Picus J, Sharfman WH, Stankevich E, Pons A, Salay TM, McMiller TL, Gilson MM, Wang C, Selby M, Taube JM, Anders R, Chen L, Korman AJ, Pardoll DM, Lowy I, Topalian SL. Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates. J Clin Oncol. 2010 Jul 1;28(19):3167-75. doi: 10.1200/JCO.2009.26.7609. Epub 2010 Jun 1.
PubMed 20516446Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017 Jul 28;357(6349):409-413. doi: 10.1126/science.aan6733. Epub 2017 Jun 8.
PubMed 28596308Xu J, Zhang Y, Jia R, Yue C, Chang L, Liu R, Zhang G, Zhao C, Zhang Y, Chen C, Wang Y, Yi X, Hu Z, Zou J, Wang Q. Anti-PD-1 Antibody SHR-1210 Combined with Apatinib for Advanced Hepatocellular Carcinoma, Gastric, or Esophagogastric Junction Cancer: An Open-label, Dose Escalation and Expansion Study. Clin Cancer Res. 2019 Jan 15;25(2):515-523. doi: 10.1158/1078-0432.CCR-18-2484. Epub 2018 Oct 22.
PubMed 30348638Mei Q, Zhang W, Liu Y, Yang Q, Rasko JEJ, Nie J, Liu J, Li X, Dong L, Chen M, Zhang Y, Shi L, Wu H, Han W. Camrelizumab Plus Gemcitabine, Vinorelbine, and Pegylated Liposomal Doxorubicin in Relapsed/Refractory Primary Mediastinal B-Cell Lymphoma: A Single-Arm, Open-Label, Phase II Trial. Clin Cancer Res. 2020 Sep 1;26(17):4521-4530. doi: 10.1158/1078-0432.CCR-20-0514. Epub 2020 Jun 4.
PubMed 32499235Shirley M. Fruquintinib: First Global Approval. Drugs. 2018 Nov;78(16):1757-1761. doi: 10.1007/s40265-018-0998-z.
PubMed 30357594
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Label, Phase II, Exploratory Study of Fruquitinib Combined With Camrelizumab in Non MSI-H / dMMR Refractory Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT04866862
- Acronym / sponsor ID
- KEEP-G 05
- Conditions
- Colorectal Neoplasm
- Keywords
- colorectal cancer, non MSI-H/dMMR, Camrelizumab, Fruquintinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 30 Apr 2021 (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.
Limited agents are optional after standard first and second line treatment for mCRC. Nowadays, cancer therapy has entered the era of immunotherapy. The approved cancer therapies include pembrolizumab and nivolumab, but only for MSI-H patients. 95% of non MSI-H / dMMR patients with advanced colorectal cancer can not benefit from them. Therefore, the use of PD-1 / PD-L1 monoclonal antibody in mCRC is greatly limited. Our previous research showed that anti-PD-1 combined with Fruquintinib can significantly inhibit the growth of CRC in MSS mice. At the same time, a retrospective clinical study showed that patients with MSS CRC can benefit from Sintilimab combined with Fruquintinib. Camrelizumab is PD-1 monoclonal antibody, which has been approved for a variety of tumors. The prospective clinical trial of Camrelizumab combined with Fruquintinib may bring new hope for the treatment of non MSI-H / dMMR patients with mCRC.This study is aimed to explore the efficacy, safety in advanced colorectal cancer failed to standard therapy in Chinese population.
Detailed description
Our previous research showed that anti-PD-1 combined with Fruquintinib can significantly inhibit the growth of CRC in MSS mice. At the same time, a retrospective clinical study showed that patients with MSS CRC can benefit from Sintilimab combined with Fruquintinib. Camrelizumab is PD-1 monoclonal antibody, which has been approved for a variety of tumors. The prospective clinical trial of Camrelizumab combined with Fruquintinib may bring new hope for the treatment of non MSI-H / dMMR patients with mCRC.This study is aimed to explore the efficacy, safety in advanced colorectal cancer failed to standard therapy in Chinese population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination of Fruquintinib and Camrelizumab | Experimental | Drug: Combination of Fruquintinib and CamrelizumabFruquintinib 5mg d1-21+ Camrelizumab 200mg d1; Repeated every 4 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
- Subjects with non MSI-H / dMMR metastatic colorectal cancer(CRC) (Stage IV)
- Subjects must have failed at least two lines of prior treatment, which must include a fluoropyrimidine, oxaliplatin and irinotecan.
- Subjects must not have been treated with Fruquitinib or any anti-PD-1 inhibitors.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.is necessary.
Key exclusion criteria (16 listed)
- Subjects are severe malnutrition or need tube feeding.
- Radiotherapy or surgery has been performed within 30 days before treatment.
- Previous treatment with anti-PD-1 / PD-L1 inhibitor and / or fruquitinib.
- Other malignant tumors within 2 years and without cure (except for cured basal cell carcinoma of skin and carcinoma in situ of cervix);
- Subjects have active autoimmune system diseases、systemic hormone therapy or anti autoimmune drug therapy.
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 |
|---|---|---|
| Combination of Fruquintinib and CamrelizumabAlso: Fruquintinib 5mg d1-21+Camrelizumab 200 mg d1Fruquintinib 5mg d1-21+Camrelizumab 200 mg d1 | Drug | Combination of Fruquintinib and Camrelizumab |
Primary outcome
Objective response rate(ORR)
Time frame: up to 2 years
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)
4 secondary outcomes
Progression-free Survival(PFS)
Time frame: From date of subjects until the date of first documented progression or death from any cause, whichever came first, assessed up to 24 months
Overall Survival (OS)
Time frame: From assignment of the first subject until 32 death events observed, up to 2 years.
Disease control rate (DCR)
Time frame: up to 2 years
Tumor Mutation Burden (TMB)
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Results publication: PubMed 31481761Jacquelot N, Yamazaki T, Roberti MP, Duong CPM, Andrews MC, Verlingue L, Ferrere G, Becharef S, Vetizou M, Daillere R, Messaoudene M, Enot DP, Stoll G, Ugel S, Marigo I, Foong Ngiow S, Marabelle A, Prevost-Blondel A, Gaudreau PO, Gopalakrishnan V, Eggermont AM, Opolon P, Klein C, Madonna G, Ascierto PA, Sucker A, Schadendorf D, Smyth MJ, Soria JC, Kroemer G, Bronte V, Wargo J, Zitvogel L. Sustained Type I interferon signaling as a mechanism of resistance to PD-1 blockade. Cell Res. 2019 Oct;29(10):846-861. doi: 10.1038/s41422-019-0224-x. Epub 2019 Sep 3.
- Results publication: PubMed 20516446Brahmer JR, Drake CG, Wollner I, Powderly JD, Picus J, Sharfman WH, Stankevich E, Pons A, Salay TM, McMiller TL, Gilson MM, Wang C, Selby M, Taube JM, Anders R, Chen L, Korman AJ, Pardoll DM, Lowy I, Topalian SL. Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates. J Clin Oncol. 2010 Jul 1;28(19):3167-75. doi: 10.1200/JCO.2009.26.7609. Epub 2010 Jun 1.
- Results publication: PubMed 28596308Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017 Jul 28;357(6349):409-413. doi: 10.1126/science.aan6733. Epub 2017 Jun 8.
- Results publication: PubMed 30348638Xu J, Zhang Y, Jia R, Yue C, Chang L, Liu R, Zhang G, Zhao C, Zhang Y, Chen C, Wang Y, Yi X, Hu Z, Zou J, Wang Q. Anti-PD-1 Antibody SHR-1210 Combined with Apatinib for Advanced Hepatocellular Carcinoma, Gastric, or Esophagogastric Junction Cancer: An Open-label, Dose Escalation and Expansion Study. Clin Cancer Res. 2019 Jan 15;25(2):515-523. doi: 10.1158/1078-0432.CCR-18-2484. Epub 2018 Oct 22.
- Results publication: PubMed 32499235Mei Q, Zhang W, Liu Y, Yang Q, Rasko JEJ, Nie J, Liu J, Li X, Dong L, Chen M, Zhang Y, Shi L, Wu H, Han W. Camrelizumab Plus Gemcitabine, Vinorelbine, and Pegylated Liposomal Doxorubicin in Relapsed/Refractory Primary Mediastinal B-Cell Lymphoma: A Single-Arm, Open-Label, Phase II Trial. Clin Cancer Res. 2020 Sep 1;26(17):4521-4530. doi: 10.1158/1078-0432.CCR-20-0514. Epub 2020 Jun 4.
- Results publication: PubMed 30357594Shirley M. Fruquintinib: First Global Approval. Drugs. 2018 Nov;78(16):1757-1761. doi: 10.1007/s40265-018-0998-z.
- Individual participant dataSharing planned: No
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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.
Rui Wang study chair
the first affilated hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combination of Fruquintinib and Camrelizumab in people with Colorectal Neoplasm, run by The First Affiliated Hospital with Nanjing Medical University 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 13 inclusion and 16 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 25 Jul 2022. 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 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 Yanhong Gu, Dr (00862568306714, guluer@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate(ORR) (time frame: up to 2 years). 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 NCT04866862, which also lists 6 linked publications.
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 25 Jul 2022.