---
title: Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
nct_id: NCT02677597
overall_status: UNKNOWN
phase: PHASE3
sponsor: Fudan University
study_type: INTERVENTIONAL
primary_condition: Esophageal Squamous Cell Carcinoma
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02677597.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02677597"
ct_last_update_post_date: 2016-02-09
last_seen_at: "2026-05-12T06:06:59.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma

**Official Title:** An Open, Multicenter, Randomized Phase III Clinical Study on Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma

**NCT ID:** [NCT02677597](https://clinicaltrials.gov/study/NCT02677597)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 268
- **Lead Sponsor:** Fudan University
- **Conditions:** Esophageal Squamous Cell Carcinoma
- **Start Date:** 2016-01
- **Completion Date:** 2019-01
- **CT.gov Last Update:** 2016-02-09

## Brief Summary

Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Histologically proven primary thoracic esophageal squamous cell carcinoma
* Not suitable for surgery or radio or chemical therapy
* Presence of at least one index lesion measurable by CT scan or MRI radiation therapy ended at least 4 weeks, but part of the radiation does not as a measurable lesions
* 18\~70 years
* PS:0-1
* Life expectancy of ≥ 3 months
* WBC≥3.5×109/L,ANC≥1.5×109/L, PLT≥100×109/L, Hb≥100g/L
* TB ≤ 1.5UNL, ALT/AST ≤ 2.5×UNL
* Scr≥60 mL/min
* Normal electrocardiogram (ecg)
* Can normal oral drugs
* Signed written informed consent

Exclusion Criteria:

* Breast-feeding or pregnant women, no effective contraception if risk of conception exists
* Chronic diarrhea, enteritis, intestine obstruction which are not under control
* Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.
* A second primary tumor (except skin basal cell carcinoma)
* The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension
* With uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or - CNS metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms
* With bleeding tendency
* Has inherited bleeding evidence of physical or blood coagulation disorder
* With clear chemotherapy drug allergy
* Other researchers believe that patients should not participate in this testing
```

## Arms

- **Cisplatin Combined With S-1** (EXPERIMENTAL) — Cisplatin 75mg/m2 ivgtt d1 S-1 BSA\<1.5 50mg bid，BSA≥1.5 60mg bid po d1-14
- **Cisplatin Combined With Paclitaxel** (EXPERIMENTAL) — Cisplatin 75mg/m2 ivgtt d1 Paclitaxel 175mg/m2 d1 ivgtt 3h

## Interventions

- **Cisplatin Combined With S-1** (DRUG)
- **Cisplatin Combined With Paclitaxel** (DRUG)

## Primary Outcomes

- **PFS** _(time frame: Since the date of random to disease progression or any cause of death，the average time is 2 years)_

## Locations (1)

- Cancer hospital Fudan University, Shanghai, Shanghai Municipality, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `locations.cancer hospital fudan university|shanghai|shanghai municipality|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02677597.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02677597*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*