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Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine as First Line Treatment in Advanced mCRC

ConditionsCRCMetastatic Colorectal CancerMetastatic Colorectal Adenocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorZhejiang Cancer Hospital

About this trial

The aim of this study is to evaluate the efficacy and safety of short course radiotherapy followed by fruquintinib combined with Sintilimab as the first-line treatment of advanced mCRC compared to bevacizumab combined with capecitabine in patients unfit for intensive therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have signed an informed consent;

18 to 85 years old (including 18 and 85 years old);

Histopathologically confirmed unresectable advanced metastatic colorectal adenocarcinoma;

Have not received anti-tumor treatment for metastatic disease;

Disqualifiers

Currently has a disease or condition that affects drug absorption, or the patient is unable to take oral drugs;

Currently has digestive tract diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions determined by the researcher that may cause gastrointestinal bleeding or perforation;

History of serious cardiovascular and cerebrovascular diseases;

Other malignant tumors within the past 5 years, excluding skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental

    Drug

    SCRT: 5\*5Gy for 5 days, after a one-week rest, with fruquintinib plus sintilimab followed; Fruquintinib: qd po, 4mg/d, 2weeks on/1 week off, q3w; Sintilimab: intravenous infusion, 200mg, on day 1, q3w.

  • Active Comparator

    Drug

    Capecitabine: bid po, 1000mg/m², on days 1-14, q3w; Bevacizumab: intravenous infusion, 7.5mg/kg, on day 1, q3w.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: SCRT + fruquintinib + sintilimabExperimental treatment 1 intervention
Group B: Bevacizumab + CapecitabineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1b - Objective Response Rate (ORR)

ORR according to RECIST v1.1, as assessed by the Investigator

Time frame
From randomization until disease progression (up to approximately 3-5 years)
2

Phase 2 - Progression-free Survival (PFS)

PFS according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by the Investigator

Time frame
From randomization until disease progression (up to approximately 3-5 years)

Secondary outcomes

1

Tolerability and safety of study regimens

Number of Participants With Treatment-emergent Adverse Events (TEAEs) according to CTCAE v5.0

Time frame
From randomization until the end of treatment (up to approximately 3-5 years)
2

Disease Control Rate (DCR)

DCR according to RECIST v1.1, as assessed by the Investigator

Time frame
From randomization until disease progression (up to approximately 3-5 years)
3

Overall Survival OS)

OS according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by the Investigator

Time frame
From randomization until disease progression (up to approximately 3-5 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: