Trial · NCT03946917
JS001 Combined With Regorafenib in Patients With Advanced Colorectal Cancer
NCT03946917, Phase 1, Phase 2, Unknown, Sun Yat-sen University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. JS001 Combined With Regorafenib in Patients With Advanced Colorectal Cancer. Trials, record NCT03946917. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03946917
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- JS001 Combined With Regorafenib in Patients With Advanced Colorectal Cancer
- NCT number
- NCT03946917
- Status
- Unknown
- Phases
- Phase 1, Phase 2
- Enrollment
- 44 participants, actual
- Lead sponsor
- Sun Yat-sen University
- Conditions
- Colorectal Cancer
- Interventions
- JS001, regorafenib tablet
- First posted
- 2019-05-13
- Last updated
- 2020-05-12
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) | 28 days after the first dose of JS001 and Regorafenib, assessed up to 8 months | The maximum dose that patients enrolled can tolerate during dose escalation of phase I clinical trial according to mTPI method |
| Primary | Dose limiting toxicity (DLT) | 28 days after the first dose of JS001 and Regorafenib, assessed up to 8 months | Severe toxicity that may be related to JS001 or regorafenib during dose escalation of phase I clinical trial according to mTPI method |
| Primary | Objective response rate (ORR) | from the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | The ratio of patients who are evaluated as CR or PR |
| Secondary | Progression free survival (PFS) | from the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | The Kaplan-Meier survival from the initiation date of first cycle until the date of first documented progression or date of death |
| Secondary | Overall survival (OS) | from the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date. |
| Secondary | Disease control rate (DCR) | from the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | Defined as the proportion of patients whose tumors shrink or remain stable for a certain period of time, including CR, PR and SD. |
| Secondary | Duration of response (DOR) | the first assessment of a tumor as PR or CR and the first assessment as PD or any cause of death or the last follow-up date, assessed up to 2 years. | defined as the time between the first assessment of a tumor as PR or CR and the first assessment as PD or any cause of death |
| Secondary | Severe toxicity | from the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | ≥ Grade 3 toxicities |
| Secondary | cfDNA | from the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | The dynamic variation of circulating free DNA or cell free DNA (cfDNA) in immunotherapy efficacy and safety assessment |
| Secondary | Intestinal microorganism | from the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | The composition of intestinal microorganism pre- and post-treatment tested by intestinal microorganism, the relationship between intestinal flora alpha diversity and beta diversity and immunotherapy response as well as between intestinal microorganism alpha diversity and beta diversity and treatment toxicity and tolerance. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03946917
GET https://conductscience.org/api/trials/v1/NCT03946917/registered