Trial · NCT07109401
Perioperative Immunotherapy for Resectable Limited-Stage SCLC
NCT07109401, Phase 2, Recruiting, Fudan University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Perioperative Immunotherapy for Resectable Limited-Stage SCLC. Trials, record NCT07109401. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07109401
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Perioperative Immunotherapy for Resectable Limited-Stage SCLC
- NCT number
- NCT07109401
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 37 participants, estimated
- Lead sponsor
- Fudan University
- Conditions
- Perioperative Immunotherapy, Limited Stage Lung Small Cell Carcinoma, Resectable Small Cell Lung Cancer
- Interventions
- Tislelizumab (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide)
- First posted
- 2025-08-07
- Last updated
- 2025-08-07
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | One-year Event-free Survival Rate (1-year EFS Rate) | Up to 12 months | The proportion of patients who have not experienced an EFS event within 1 year after the first administration of the study drug. EFS (Event-Free Survival) is defined as the time from the first dose of study treatment until the first occurrence of any of the following events: objectively documented disease progression and inability to undergo radical surgery, local recurrence, distant metastasis, or death from any cause (whichever occurs first). EFS is assessed by investigators based on RECIST v1.1 (Response evaluation criteria in solid tumors v1.1) criteria within the radical curative therapy analysis set. |
| Secondary | Event-free Survival (EFS) | up to 60 months | Event-Free Survival (EFS) - defined as the time from the first dose of study treatment until the first occurrence of any of the following events: objectively documented disease progression and inability to undergo radical surgery, local recurrence, distant metastasis, or death from any cause (whichever occurs first). |
| Secondary | Overall Survival (OS) | up to 60 months | Overall Survival - defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date. |
| Secondary | Objective Response Rate (ORR) | Up to 12 months | Objective Response Rate (ORR) - defined as the proportion of patients who achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as assessed by investigators according to RECIST v1.1 criteria. |
| Secondary | Disease Control Rate (DCR) | Up to 12 months | Disease Control Rate (DCR) - defined as the proportion of patients who achieve a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), or Stable Disease (SD), as assessed by investigators according to RECIST v1.1 criteria. |
| Secondary | Pathological Complete Response (pCR) Rate | Up to 12 months | Pathological Complete Response (pCR) Rate - defined as the proportion of patients who have no residual tumor in the resected primary tumor site and all resected lymph nodes after neoadjuvant therapy among those who underwent surgical resection. |
| Secondary | Major Pathological Response (MPR) Rate | Up to 12 months | Major Pathological Response (MPR) Rate - defined as the proportion of patients who have ≤10% residual viable tumor cells in the resected primary tumor site and all resected lymph nodes after neoadjuvant therapy among those who underwent surgical resection. |
| Secondary | Pathological Downstaging Rate | Up to 12 months | Pathological Downstaging Rate - defined as the proportion of patients who undergo surgical resection after neoadjuvant therapy and have a postoperative pathological stage that is lower than their baseline clinical tumor stage and/or lymph node involvement. |
| Secondary | R0 Resection Rate | Up to 12 months | R0 Resection Rate - defined as the proportion of patients who achieve complete tumor resection (negative margins with no residual tumor cells) among those who underwent surgical resection after neoadjuvant therapy. |
| Secondary | Clinical Downstaging Rate | Up to 12 months | Clinical Downstaging Rate - defined as the proportion of patients who have a reduction in tumor size and/or lymph node involvement in their clinical tumor stage after neoadjuvant therapy compared to their baseline clinical tumor stage before surgery. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT07109401
GET https://conductscience.org/api/trials/v1/NCT07109401/registered